npm - @memoarchitect/architect - Versions diffs - 0.6.2 → 0.6.4 - Mend

@memoarchitect/architect 0.6.2 → 0.6.4

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package/dist/assets/index-D0i9ua6F.js DELETED Viewed

@@ -1,3277 +0,0 @@
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0.1s"},onMouseEnter:p=>p.currentTarget.style.background=y.surfaceAlt,onMouseLeave:p=>p.currentTarget.style.background="transparent",children:t.jsxs("div",{style:{flex:1,minWidth:0},children:[t.jsx("div",{style:{fontSize:j.explorer.item,fontWeight:500,color:y.primary,whiteSpace:"nowrap",overflow:"hidden",textOverflow:"ellipsis"},children:d.name}),t.jsxs("div",{style:{fontSize:"10px",color:y.muted,marginTop:"2px",whiteSpace:"nowrap",overflow:"hidden",textOverflow:"ellipsis"},children:[t.jsx("span",{style:{color:c,fontWeight:600},children:d.kind}),d.shortId&&t.jsx("span",{style:{marginLeft:"6px",fontFamily:"monospace",opacity:.7},children:d.shortId})]})]})},d.id)})})]})}const Fi=`---
-id: change-record
-title: Design Change Record
-standard: 21 CFR Part 820
-clauses: ["820.30(i)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Documents design changes for **{{project.product}}** per 21 CFR 820.30(i). All changes must be evaluated for safety impact and approved before implementation.
----
-## 2. Change Log
-Record each change with its identifier, description, affected items, and verification status:
-| Change # | Date | Description | Reason | Impact Assessment | Approved By |
-| --- | --- | --- | --- | --- | --- |
-| CHG-001 | | | | | |
----
-## 3. Substantial Equivalence Assessment
-Assess substantial equivalence to the predicate device, comparing intended use and technological characteristics.
-_[TODO: For FDA-cleared devices, assess whether any changes affect substantial equivalence]_
----
-## 4. Risk Assessment for Changes
-Assess the risk impact of each change per ISO 14971, including effects on existing risk controls.
-_[TODO: Document risk management activity triggered by each significant change]_
----
-{{include:shared/snippets/revision-history-table.md}}
-`,Ri=`---
-id: design-input
-title: Design Input Plan
-standard: 21 CFR Part 820
-clauses: ["820.30(c)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-Defines design inputs for **{{project.product}}** per 21 CFR 820.30(c). Design inputs are the physical and performance requirements to which the device design must conform.
----
-## 2. Design Input Requirements
-### 2.1 Performance Requirements
-\`\`\`memo-query
-kind: Requirement
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No system requirements defined."
-\`\`\`
-### 2.2 Design Inputs from User Needs
-\`\`\`memo-query
-kind: [DesignInput, Need]
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No design inputs defined. Add DesignInput elements."
-\`\`\`
----
-## 3. Regulatory and Standards Requirements
-Complete the table below for **{{project.product}}**:
-| Standard | Requirement | Input Reference |
-| --- | --- | --- |
-| 21 CFR 820.30 | Design controls | |
-| ISO 14971 | Risk management requirements | |
-| IEC 62304 | Software development | |
----
-## 4. Design Input Review
-Record the review of design inputs for completeness, unambiguity, and absence of conflicts per 21 CFR 820.30(c).
-_[TODO: Document the design input review process and sign-off]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Ti=`---
-id: design-output
-title: Design Output Plan
-standard: 21 CFR Part 820
-clauses: ["820.30(d)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-Defines design outputs for **{{project.product}}** per 21 CFR 820.30(d). Design outputs are the results of the design process, forming the basis for manufacturing.
----
-## 2. Design Outputs
-### 2.1 Hardware Design Outputs
-\`\`\`memo-query
-kind: [Component, Subsystem, DesignOutput]
-where: layer == "physical"
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No hardware design outputs defined."
-\`\`\`
-### 2.2 Software Design Outputs
-\`\`\`memo-query
-kind: [SoftwareItem, SoftwareUnit, DesignOutput]
-where: layer == "software"
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No software design outputs defined."
-\`\`\`
-### 2.3 All Design Outputs
-\`\`\`memo-query
-kind: DesignOutput
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No DesignOutput elements defined. Add DesignOutput elements."
-\`\`\`
----
-## 3. Design Output → Input Traceability
-Traceability from design outputs back to design inputs, generated live from the model:
-_[TODO: Demonstrate that each design output meets a design input requirement]_
----
-## 4. Essential Design Output Documents
-List the documents constituting the essential design outputs for the DHF.
-| Document | Description | Status |
-| --- | --- | --- |
-| Engineering drawings | Physical design specifications | |
-| Software architecture | Software design specifications | |
-| Manufacturing specs | Production procedures | |
-| Labeling | Device labels and IFU | |
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Ii=`---
-id: design-review
-title: Design Review Record
-standard: 21 CFR Part 820
-clauses: ["820.30(e)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Documents formal design reviews for **{{project.product}}** per 21 CFR 820.30(e).
----
-## 2. Design Review Log
-Record of formal design reviews with dates, participants, and outcomes:
-| Review | Date | Stage | Attendees | Outcome | Actions |
-| --- | --- | --- | --- | --- | --- |
-| DR-001 | | Preliminary Design | | | |
-| DR-002 | | Critical Design | | | |
-| DR-003 | | Final Design | | | |
----
-## 3. Open Action Items
-Action items raised during review, their owners, and due dates:
-_[TODO: Track all open action items from design reviews]_
----
-## 4. Design Status at Review
-Snapshot of the design state at the time of review, computed from the model:
-\`\`\`memo-query
-kind: [Requirement, Requirement, DesignInput, DesignOutput]
-display: count
-label: Total design elements at last review
-\`\`\`
----
-{{include:shared/snippets/revision-history-table.md}}
-`,_i=`---
-id: design-validation
-title: Design Validation Records
-standard: 21 CFR Part 820
-clauses: ["820.30(g)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Documents design validation confirming the device meets user needs and intended use for **{{project.product}}** per 21 CFR 820.30(g).
----
-## 2. Validation Plan Reference
-Reference the validation plan governing these activities and note any deviations from it.
-_[TODO: Reference V&V Plan]_
----
-## 3. Clinical/Bench Validation
-Describe clinical or bench validation activities demonstrating conformity with user needs under actual or simulated use conditions.
-\`\`\`memo-query
-kind: ValidationActivity
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No validation activities defined."
-\`\`\`
----
-## 4. User Need Coverage
-Coverage of user needs by validation activities, computed live from the model:
-\`\`\`memo-query
-kind: [Need, Requirement]
-display: table
-columns: name, layer, doc
-empty: "No user needs defined."
-\`\`\`
----
-## 5. Conclusion
-Summarize the outcome and state the overall conclusion, including any conditions or follow-up actions.
-_[TODO: State validation conclusion — device meets intended use for intended users]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Ni=`---
-id: design-verification
-title: Design Verification Records
-standard: 21 CFR Part 820
-clauses: ["820.30(f)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Documents design verification that design outputs meet design inputs for **{{project.product}}** per 21 CFR 820.30(f).
----
-## 2. Verification Matrix
-The verification traceability below is generated live from the model — every requirement should be covered by at least one verification activity:
-\`\`\`memo-query
-kind: VerificationActivity
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No verification activities defined."
-\`\`\`
----
-## 3. Test Results
-Test executions and their outcomes are summarized below from the model:
-\`\`\`memo-query
-kind: TestCase
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No test cases defined."
-\`\`\`
----
-## 4. Design Input Coverage
-Coverage of design inputs by verification activities, computed live from the model:
-_[TODO: Demonstrate that all design inputs are verified by at least one test]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Mi=`---
-id: dhf-index
-title: Design History File Index
-standard: 21 CFR Part 820
-clauses: ["820.30(j)", "ISO 13485:2016 §4.2.4"]
-required_for: ["FDA_510k", "FDA_PMA", "CE", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Design History File (DHF) Index serves as the master index for all design and development records for **{{project.product}}** per 21 CFR 820.30(j).
----
-## 2. Device Summary
-Key characteristics of **{{project.product}}**, drawn from the model:
-| Field | Value |
-| --- | --- |
-| Device Name | {{project.product}} |
-| Company | {{project.company}} |
-| Device Type | {{project.device_type}} |
-| Development Phase | {{project.phase}} |
-| Version | {{project.version}} |
----
-## 3. DHF Documents
-### Risk Management
-| Document | Standard | Status |
-| --- | --- | --- |
-| Risk Management Plan | ISO 14971:2019 §4.4 | |
-| Hazard Analysis Report | ISO 14971:2019 §5-7 | |
-| FMEA | IEC 60812:2018 | |
-| Risk Management Report | ISO 14971:2019 §9 | |
-### Design Controls
-| Document | Standard | Status |
-| --- | --- | --- |
-| User Needs | 21 CFR 820.30(c) | |
-| Design Input Plan | 21 CFR 820.30(c) | |
-| Design Output Plan | 21 CFR 820.30(d) | |
-| V&V Plan | 21 CFR 820.30(f-g) | |
-| V&V Report | 21 CFR 820.30(f-g) | |
-| Design Transfer Plan | 21 CFR 820.30(h) | |
-### Software Documentation
-| Document | Standard | Status |
-| --- | --- | --- |
-| Software Development Plan | IEC 62304 §5.1 | |
-| Software Requirements Specification | IEC 62304 §5.2 | |
-| Software Architecture Description | IEC 62304 §5.3 | |
-| SOUP List | IEC 62304 §8.1.2 | |
-| Software Traceability Matrix | IEC 62304 §5.7.5 | |
-### Usability Engineering
-| Document | Standard | Status |
-| --- | --- | --- |
-| Usability Engineering Plan | IEC 62366-1 §4 | |
-| Use-Related Risk Analysis | IEC 62366-1 §5 | |
-| Summative Evaluation Report | IEC 62366-1 §5.9 | |
----
-## 4. Model Summary
-Summary statistics of the system model at the time this document was generated:
-\`\`\`memo-query
-kind: [Requirement, Requirement]
-display: count
-label: Total requirements
-\`\`\`
-\`\`\`memo-query
-kind: Hazard
-display: count
-label: Total hazards
-\`\`\`
-\`\`\`memo-query
-kind: [TestCase, VerificationActivity]
-display: count
-label: Total test cases
-\`\`\`
----
-## 5. All Model Elements
-{{glossary}}
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,Oi=`---
-id: transfer-plan
-title: Design Transfer Plan
-standard: 21 CFR Part 820
-clauses: ["820.30(h)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Defines design transfer activities for **{{project.product}}** per 21 CFR 820.30(h), ensuring device design is correctly translated to production specifications.
----
-## 2. Transfer Checklist
-Checklist of items required before design transfer to production is complete:
-| Activity | Responsible | Completion Date | Status |
-| --- | --- | --- | --- |
-| Engineering drawings released to production | | | |
-| Software build process documented | | | |
-| Production procedures validated | | | |
-| Test equipment calibrated | | | |
-| Production personnel trained | | | |
-| First article inspection completed | | | |
----
-## 3. Production Specifications
-Production specifications derived from the design outputs:
-\`\`\`memo-query
-kind: DesignOutput
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No design outputs defined."
-\`\`\`
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Pi=`---
-id: user-needs
-title: User Needs Document
-standard: 21 CFR Part 820
-clauses: ["820.30(c)"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This document captures user needs for **{{project.product}}** per 21 CFR 820.30(c) Design Input requirements. User needs represent the intended purpose of the device as stated by customers and intended users.
----
-## 2. Intended Users
-Identify every intended user group of **{{project.product}}**, including their roles, training assumptions, and use environments.
-_[TODO: Describe all intended user groups with their roles, training levels, and environments]_
----
-## 3. User Needs
-User needs captured for **{{project.product}}** are listed below from the model. Each user need should trace forward to at least one design input:
-\`\`\`memo-query
-kind: [Need, Requirement]
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No user need elements defined. Add Need or Requirement elements."
-\`\`\`
----
-## 4. Use Cases
-Use cases describing how intended users interact with **{{project.product}}**, drawn from the model:
-\`\`\`memo-query
-kind: UseCase
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No use cases defined."
-\`\`\`
----
-## 5. Customer Requirements
-List customer-stated requirements that serve as input to the design process.
-_[TODO: List customer-stated requirements as input to the design process]_
----
-## 6. Regulatory Requirements
-Regulatory and standards requirements applicable to **{{project.product}}**:
-| Standard | Applicability | Notes |
-| --- | --- | --- |
-| 21 CFR Part 820 | Quality System Regulation | |
-| IEC 62304 | Software lifecycle | If Class B/C SW |
-| ISO 14971 | Risk management | |
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,zi=`---
-id: vv-plan
-title: Verification and Validation Plan
-standard: 21 CFR Part 820
-clauses: ["820.30(f)", "820.30(g)"]
-required_for: ["FDA_510k", "FDA_PMA", "CE"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This V&V Plan defines verification and validation activities for **{{project.product}}** per 21 CFR 820.30(f)-(g) and ISO 13485:2016 §7.3.6-7.3.7.
----
-## 2. Scope
-This plan covers:
-- Software verification (per IEC 62304 §5.6-5.7)
-- Hardware verification
-- System-level validation
-- Usability validation (per IEC 62366-1)
----
-## 3. Verification Activities
-### 3.1 Requirements to Verify
-\`\`\`memo-query
-kind: [Requirement, Requirement]
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No requirements defined."
-\`\`\`
-### 3.2 Verification Test Cases
-\`\`\`memo-query
-kind: [TestCase, VerificationActivity]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No verification test cases defined."
-\`\`\`
----
-## 4. Validation Activities
-Validation activities demonstrating that **{{project.product}}** meets user needs and intended uses:
-\`\`\`memo-query
-kind: ValidationActivity
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No validation activities defined."
-\`\`\`
----
-## 5. Acceptance Criteria
-State the objective criteria that must be met for the validation to be considered successful.
-_[TODO: Define objective acceptance criteria for all V&V activities]_
----
-## 6. Test Environment
-Describe the hardware, software, tools, and configuration of the test environment in sufficient detail to reproduce the test setup.
-_[TODO: Describe hardware, software, and clinical test environments]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,Bi=`---
-id: vv-report
-title: Verification and Validation Report
-standard: 21 CFR Part 820
-clauses: ["820.30(f)", "820.30(g)"]
-required_for: ["FDA_510k", "FDA_PMA", "CE"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This V&V Report documents the results of all verification and validation activities for **{{project.product}}**.
----
-## 2. Summary
-Summary metrics computed live from the model:
-\`\`\`memo-query
-kind: TestCase
-display: count
-label: Total test cases
-\`\`\`
-\`\`\`memo-query
-kind: [VerificationActivity, ValidationActivity]
-display: count
-label: V&V activities
-\`\`\`
----
-## 3. Verification Results
-### 3.1 Test Results by Requirement
-\`\`\`memo-query
-kind: [TestCase, VerificationActivity]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No verification activities defined."
-\`\`\`
----
-## 4. Validation Results
-Results of the validation activities are summarized below:
-\`\`\`memo-query
-kind: ValidationActivity
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No validation activities defined."
-\`\`\`
----
-## 5. Known Anomalies and Deviations
-Record any anomalies, deviations from plan, and their disposition, including rationale for acceptance of unresolved anomalies.
-_[TODO: List any unresolved anomalies and provide justification for acceptance]_
----
-## 6. V&V Conclusion
-State the overall verification and validation conclusion for **{{project.product}}**, including any conditions, limitations, or required follow-up actions.
-_[TODO: State whether the device meets all design inputs and is fit for intended use]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Li=`---
-id: incident-response
-title: Cybersecurity Incident Response Plan
-standard: FDA Cybersecurity Guidance 2023
-clauses: ["5.2"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Defines the incident response process for cybersecurity events affecting **{{project.product}}**.
----
-## 2. Incident Classification
-Define the severity classes for security incidents and the criteria for assigning them.
-| Class | Description | Response Time | FDA Reporting |
-| --- | --- | --- | --- |
-| Class 1 | Exploited vulnerability affecting device safety | 24 hours | Required within 30 days |
-| Class 2 | Unpatched but known vulnerability | 72 hours | Likely required |
-| Class 3 | Suspected security event | 5 days | Assess case-by-case |
----
-## 3. Response Team
-Identify the incident response team members, their roles, and contact paths.
-| Role | Responsible Party | Contact |
-| --- | --- | --- |
-| Incident Commander | | |
-| Security Lead | | |
-| Regulatory Affairs | | |
-| Clinical Safety | | |
-| Legal/Compliance | | |
----
-## 4. Response Procedure
-1. Detection and initial assessment
-2. Containment of affected devices
-3. Impact analysis (patient safety, data)
-4. Develop and test patch
-5. Deploy and verify patch
-6. FDA notification (if required)
-7. Customer notification
-8. Post-incident review
----
-## 5. Coordinated Vulnerability Disclosure
-Describe the process by which external researchers can report vulnerabilities and how reports are triaged and disclosed.
-_[TODO: Describe the coordinated disclosure policy for external researchers]_
----
-{{include:shared/snippets/revision-history-table.md}}
-`,qi=`---
-id: postmarket-surveillance
-title: Post-Market Cybersecurity Surveillance Plan
-standard: FDA Cybersecurity Guidance 2023
-clauses: ["5"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Defines ongoing cybersecurity surveillance for **{{project.product}}** in the post-market phase per FDA's 2023 guidance.
----
-## 2. Surveillance Sources
-- NVD / CVE database monitoring for SOUP vulnerabilities
-- ICS-CERT / FDA MedSun cybersecurity alerts
-- Vulnerability reports from customers and researchers
-- Threat intelligence feeds
----
-## 3. SOUP Monitoring
-Describe the process for ongoing monitoring of SOUP components for newly published vulnerabilities.
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, doc
-sort: name
-empty: "No SOUP components to monitor."
-\`\`\`
----
-## 4. Response Timelines
-Define target timelines for triage, containment, remediation, and notification per incident class.
-| Severity | CVSS Score | Response Target |
-| --- | --- | --- |
-| Critical | 9.0–10.0 | 30 days |
-| High | 7.0–8.9 | 60 days |
-| Medium | 4.0–6.9 | 90 days |
-| Low | < 4.0 | Next release |
----
-## 5. Patch and Update Process
-Describe how security patches are developed, verified, approved, and deployed to fielded devices.
-_[TODO: Describe how security patches are tested, validated, and released]_
----
-{{include:shared/snippets/revision-history-table.md}}
-`,Vi=`---
-id: security-arch
-title: Cybersecurity Architecture Description
-standard: FDA Cybersecurity Guidance 2023
-clauses: ["3.3"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-Describes the cybersecurity architecture for **{{project.product}}** per FDA's 2023 guidance and IEC 81001-5-1:2021.
----
-## 2. Security Architecture
-This section describes the security architecture of **{{project.product}}**. The security-relevant elements below are drawn from the model:
-{{diagram:security-architecture}}
----
-## 3. Trusted Zones and Communication Paths
-Define the trusted zones, the communication paths crossing zone boundaries, and the protection applied at each crossing.
-\`\`\`memo-query
-kind: Interface
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No interfaces defined."
-\`\`\`
----
-## 4. Security Controls
-Security controls implemented in **{{project.product}}** are listed below from the model. Each control should trace to at least one identified threat:
-\`\`\`memo-query
-kind: SecurityControl
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No security controls defined."
-\`\`\`
----
-## 5. Cybersecurity Design Principles Applied
-Describe how core security principles (least privilege, defense in depth, secure defaults, fail secure) are applied in the design.
-_[TODO: Document which NIST CSF or IEC 81001-5-1 principles are applied]_
-| Principle | Implementation | Reference |
-| --- | --- | --- |
-| Least privilege | | |
-| Defense in depth | | |
-| Fail secure | | |
-| Cryptographic controls | | |
-| Secure boot | | |
----
-## 6. Security Testing
-Describe the security testing performed (e.g. static analysis, fuzzing, penetration testing) and reference the detailed results.
-_[TODO: Describe penetration testing, vulnerability scanning, and security code review]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,$i=`---
-id: threat-model
-title: Cybersecurity Threat Model
-standard: FDA Cybersecurity Guidance 2023
-clauses: ["3.2"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This threat model documents cybersecurity threats for **{{project.product}}** per FDA's 2023 Cybersecurity in Medical Devices guidance and IEC 81001-5-1:2021.
----
-## 2. System Assets
-Assets requiring protection (data, functions, interfaces), drawn from the model:
-\`\`\`memo-query
-kind: [SoftwareSystem, Interface, SOUPComponent]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No system assets defined."
-\`\`\`
----
-## 3. Entry Points and Attack Surface
-Entry points and externally reachable interfaces constituting the attack surface, drawn from the model:
-\`\`\`memo-query
-kind: Interface
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No interfaces defined."
-\`\`\`
----
-## 4. Threat Catalog
-The threat catalog below is generated from the model. Each threat should be assessed for likelihood and impact and trace to mitigating security controls:
-\`\`\`memo-query
-kind: ThreatModel
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No threat model elements defined. Add ThreatModel elements."
-\`\`\`
-### 4.1 STRIDE Analysis
-| Threat Category | Description | Affected Assets | Likelihood | Impact |
-| --- | --- | --- | --- | --- |
-| Spoofing | | | | |
-| Tampering | | | | |
-| Repudiation | | | | |
-| Information Disclosure | | | | |
-| Denial of Service | | | | |
-| Elevation of Privilege | | | | |
----
-## 5. Security Controls
-Security controls implemented in **{{project.product}}** are listed below from the model. Each control should trace to at least one identified threat:
-\`\`\`memo-query
-kind: SecurityControl
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No security controls defined."
-\`\`\`
----
-## 6. Unmitigated Threats
-Threats without a mitigating security control are surfaced below by a live model query — this list should be empty before release:
-_[TODO: List any threats without security controls and provide residual risk justification]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,Ui=`---
-id: vuln-assessment
-title: Vulnerability Assessment and Penetration Testing Report
-standard: FDA Cybersecurity Guidance 2023
-clauses: ["3.4"]
-required_for: ["FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-Documents cybersecurity vulnerability assessment and testing for **{{project.product}}** per FDA's 2023 cybersecurity guidance.
----
-## 2. Scope of Assessment
-Define the boundaries of this assessment: components, interfaces, and threat classes in and out of scope.
-\`\`\`memo-query
-kind: [SoftwareSystem, SoftwareItem, Interface]
-display: table
-columns: name, kind, layer
-sort: name
-empty: "No software assets defined."
-\`\`\`
----
-## 3. SOUP/Third-Party Component Vulnerabilities
-Known vulnerabilities in SOUP and third-party components (e.g. from CVE/NVD monitoring) and their disposition:
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, doc
-sort: name
-empty: "No SOUP components defined."
-\`\`\`
----
-## 4. Vulnerability Findings
-Identified vulnerabilities and their assessment are listed below:
-| CVE / Finding | Component | Severity (CVSS) | Status | Mitigation |
-| --- | --- | --- | --- | --- |
-| | | | | |
----
-## 5. Penetration Test Results
-Summarize the scope, methodology, and findings of penetration testing.
-_[TODO: Summarize penetration testing scope, methodology, and findings]_
----
-## 6. Residual Vulnerabilities
-Vulnerabilities remaining after mitigation, with the rationale for their acceptability:
-_[TODO: Document any accepted residual vulnerabilities with justification]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Wi=`---
-id: change-control
-title: Software Change Control Log
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["6"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-This log documents all changes to **{{project.product}}** software, including the change description, impact assessment, and approval per IEC 62304:2006 §6.
----
-## 2. Change Log
-Record each change with its identifier, description, affected items, and verification status:
-| Change ID | Date | Version | Description | Impact Assessment | Approved By |
-| --- | --- | --- | --- | --- | --- |
-| CHG-001 | | 1.0.0 | Initial release | N/A | |
----
-## 3. Change Procedure
-All changes must:
-1. Be requested via the change request process
-2. Have an impact assessment (safety, requirements, design, test)
-3. Be approved prior to implementation
-4. Be verified and validated after implementation
-5. Be documented in this log
----
-{{include:shared/snippets/revision-history-table.md}}
-`,Hi=`---
-id: detailed-design
-title: Software Detailed Design
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["5.4"]
-required_for: ["CE", "FDA_510k"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This document provides detailed design specifications for **{{project.product}}** software per IEC 62304:2006 §5.4, sufficient to implement and test each software unit.
----
-## 2. Software Units
-The software units — the lowest level of decomposition per IEC 62304 — are listed below from the model:
-\`\`\`memo-query
-kind: SoftwareUnit
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No SoftwareUnit elements defined."
-\`\`\`
----
-## 3. Unit Specifications
-### 3.1 Algorithms and Data Structures
-_[TODO: Describe key algorithms, data structures, and design patterns]_
-### 3.2 State Machines
-{{diagram:state-machine}}
-_[TODO: Document state machine diagrams for stateful components]_
-### 3.3 Interface Specifications
-\`\`\`memo-query
-kind: Interface
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No Interface elements defined."
-\`\`\`
----
-## 4. Design Verification Criteria
-The criteria used to verify that design outputs meet design inputs:
-_[TODO: List criteria that verify this design meets software requirements]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Ki=`---
-id: integration-test
-title: Software Integration Test Plan
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["5.6"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Integration Test Plan defines the approach for integration testing of **{{project.product}}** software per IEC 62304:2006 §5.6.
----
-## 2. Software Items Under Test
-The software items in scope for this test plan, drawn from the model:
-\`\`\`memo-query
-kind: [SoftwareItem, SoftwareUnit]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No software items defined."
-\`\`\`
----
-## 3. Integration Test Cases
-Integration test cases are listed below from the model:
-\`\`\`memo-query
-kind: TestCase
-where: layer == "verification"
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No integration test cases defined. Add TestCase elements."
-\`\`\`
----
-## 4. Integration Sequence
-Describe the order in which software items are integrated and tested, and the rationale for that order.
-_[TODO: Define the order in which software items are integrated and tested]_
----
-## 5. Pass/Fail Criteria
-State the objective criteria used to judge each test as passed or failed.
-_[TODO: Define objective pass/fail criteria for integration tests]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Gi=`---
-id: sad
-title: Software Architecture Description
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["5.3"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Software Architecture Description (SAD) defines the architecture of **{{project.product}}** software per IEC 62304:2006 §5.3 and ISO/IEC/IEEE 42010:2022.
----
-## 2. System Overview
-This section gives a high-level overview of the **{{project.product}}** software system. The composition below is drawn live from the architecture model:
-\`\`\`memo-query
-kind: SoftwareSystem
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No SoftwareSystem defined."
-\`\`\`
-**Total elements:**
-\`\`\`memo-query
-kind: [SoftwareSystem, SoftwareItem, SoftwareUnit, SOUPComponent]
-display: count
-label: Total software elements
-\`\`\`
----
-## 3. Software Architecture
-This section describes the decomposition of the software into software items per IEC 62304 §5.3.1. The architecture view and the element tables that follow are generated from the model:
-{{diagram:software-architecture}}
-### 3.1 Software Items
-\`\`\`memo-query
-kind: SoftwareItem
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No SoftwareItem elements defined."
-\`\`\`
-### 3.2 Software Units
-\`\`\`memo-query
-kind: SoftwareUnit
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No SoftwareUnit elements defined."
-\`\`\`
-### 3.3 Interfaces
-\`\`\`memo-query
-kind: Interface
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No Interface elements defined."
-\`\`\`
----
-## 4. SOUP Components
-Software of Unknown Provenance (SOUP) used by **{{project.product}}** is listed below per IEC 62304 §5.3.3–5.3.4. For each SOUP item, functional/performance requirements and required hardware/software must be specified:
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No SOUP components identified."
-\`\`\`
----
-## 5. Architecture Decisions
-Record the significant architecture decisions, the alternatives considered, and the rationale — including decisions driven by risk control measures (ISO 14971) or cybersecurity considerations.
-_[TODO: Document key architecture decisions and their rationale]_
----
-## 6. Software Item Segregation
-Describe the segregation between software items that is necessary for risk control per IEC 62304 §5.3.5, and the rationale for the integrity of each segregation boundary.
-_[TODO: Describe how safety-critical software items are segregated from non-safety-critical items]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,Yi=`---
-id: sbom
-title: Software Bill of Materials (SBOM)
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["8.1.2"]
-required_for: ["FDA_510k", "FDA_PMA", "CE"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Software Bill of Materials (SBOM) provides a complete inventory of software components in **{{project.product}}**, including first-party code, SOUP, and open-source dependencies. Required for FDA cybersecurity submissions and EU MDR.
----
-## 2. First-Party Software
-Software developed in-house for this system is listed below from the model:
-\`\`\`memo-query
-kind: [SoftwareSystem, SoftwareItem, SoftwareUnit]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No first-party software items defined."
-\`\`\`
----
-## 3. SOUP and Third-Party Components
-All third-party and SOUP components with their versions and origins, generated from the model:
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No SOUP components defined."
-\`\`\`
----
-## 4. Dependency Versions
-Exact component versions currently recorded in the model — keep these synchronized with the build system:
-_[TODO: Attach machine-readable SBOM (CycloneDX or SPDX format)]_
----
-## 5. Vulnerability Assessment
-Assessment of component vulnerabilities and their disposition:
-_[TODO: Reference FDA cybersecurity submission or security assessment]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,Ji=`---
-id: sdp
-title: Software Development Plan
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["5.1"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose and Scope
-This Software Development Plan (SDP) defines the processes, activities, and tasks for the development of software for **{{project.product}}**. This plan is maintained per IEC 62304:2006 §5.1.
----
-## 2. Software Classification
-<!-- [GUIDANCE] Classify software per IEC 62304 §4.3: Class A (no injury), Class B (non-serious injury), Class C (death or serious injury). -->
-| Software Item | Classification | Justification |
-| --- | --- | --- |
-| {{project.product}} Software System | Class B | |
-\`\`\`memo-query
-kind: [SoftwareSystem, SoftwareItem]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No software items defined. Add SoftwareSystem or SoftwareItem elements."
-\`\`\`
----
-## 3. Development Standards and Procedures
-Identify the coding standards, review procedures, and quality gates applied during development.
-| Activity | Standard | Reference Procedure |
-| --- | --- | --- |
-| Requirements | IEC 62304 §5.2 | SRS |
-| Architecture | IEC 62304 §5.3 | SAD |
-| Detailed Design | IEC 62304 §5.4 | SDS |
-| Implementation | IEC 62304 §5.5 | Coding standard |
-| Integration | IEC 62304 §5.6 | Integration Test Plan |
-| System Testing | IEC 62304 §5.7 | System Test Plan |
-| Release | IEC 62304 §5.8 | Release procedure |
----
-## 4. Software Safety Activities
-### 4.1 Software Items of Unknown Provenance (SOUP)
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No SOUP components defined."
-\`\`\`
-### 4.2 Software-Related Hazards
-\`\`\`memo-query
-kind: Hazard
-where: layer == "software"
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No software-related hazards defined."
-\`\`\`
----
-## 5. Configuration Management
-Describe how configuration items are identified, versioned, and controlled per IEC 62304 §8.
-_[TODO: Describe version control, branching strategy, and release process]_
----
-## 6. Problem Resolution
-Describe the problem resolution process per IEC 62304 §9, including how problems are reported, investigated, and tracked to closure.
-_[TODO: Describe defect tracking and resolution process]_
----
-## 7. Development Environment
-Describe the toolchain, languages, build system, and environments used for development.
-_[TODO: List development tools, compilers, IDEs, and their versions]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,Qi=`---
-id: soup
-title: SOUP List (Software of Unknown Provenance)
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["8.1.2"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This document lists all Software of Unknown Provenance (SOUP) components used in **{{project.product}}** per IEC 62304:2006 §8.1.2. SOUP includes off-the-shelf software, open-source libraries, and third-party components that were not developed under a quality management system.
----
-## 2. SOUP Inventory
-The complete inventory of SOUP and third-party components in **{{project.product}}**, generated from the model:
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No SOUP components defined. Add SOUPComponent elements to the model."
-\`\`\`
----
-## 3. SOUP Risk Assessment
-For each SOUP component, the potential impact on device safety must be evaluated.
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, doc
-sort: name
-empty: "No SOUP components to evaluate."
-\`\`\`
-### 3.1 Known Anomalies
-_[TODO: For each SOUP component, list known anomalies and assess impact on safety]_
----
-## 4. SOUP Maintenance
-### 4.1 Update Monitoring
-_[TODO: Describe the process for monitoring SOUP components for security patches and updates]_
-### 4.2 Version Pinning
-_[TODO: Describe how SOUP versions are pinned in configuration management]_
----
-## 5. SBOM Integration
-Describe how this document relates to the machine-readable SBOM (e.g. SPDX/CycloneDX) produced by the build pipeline.
-_[TODO: Reference Software Bill of Materials (SBOM) for FDA cybersecurity requirements]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,Xi=`---
-id: srs
-title: Software Requirements Specification
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["5.2"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Software Requirements Specification (SRS) defines the software requirements for **{{project.product}}** in accordance with IEC 62304:2006 §5.2.
----
-## 2. Requirements Summary
-Summary metrics for the requirements captured in the model:
-\`\`\`memo-query
-kind: Requirement
-display: count
-label: Total software requirements
-\`\`\`
-\`\`\`memo-query
-kind: Requirement
-display: count
-label: System requirements
-\`\`\`
----
-## 3. Functional Requirements
-Functional requirements are listed below from the model:
-\`\`\`memo-query
-kind: Requirement
-where: doc contains "shall"
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No functional software requirements defined."
-\`\`\`
-### All Software Requirements
-\`\`\`memo-query
-kind: Requirement
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No software requirements defined. Add Requirement elements to model/requirements/*.sysml."
-\`\`\`
----
-## 4. System Requirements (Allocated to Software)
-System requirements allocated to software per IEC 62304 §5.2, drawn from the model:
-\`\`\`memo-query
-kind: Requirement
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No system requirements defined."
-\`\`\`
----
-## 5. Non-Functional Requirements
-### 5.1 Performance Requirements
-_[TODO: Define performance requirements (response time, throughput, memory)]_
-### 5.2 Safety Requirements
-\`\`\`memo-query
-kind: Hazard
-where: layer == "software"
-display: table
-columns: name, doc
-sort: name
-empty: "No software safety requirements derived from hazard analysis."
-\`\`\`
-### 5.3 Security Requirements
-\`\`\`memo-query
-kind: [SecurityControl, ThreatModel]
-display: table
-columns: name, layer, doc
-empty: "No security requirements defined."
-\`\`\`
----
-## 6. SOUP Requirements
-This section is generated from the system model. The table below lists the **SOUP Requirements** elements currently defined:
-\`\`\`memo-query
-kind: SOUPComponent
-display: table
-columns: name, doc
-sort: name
-empty: "No SOUP components identified."
-\`\`\`
----
-## 7. Requirements Traceability
-This section is generated from the system model. The table below lists the **Requirements Traceability** elements currently defined:
-\`\`\`memo-query
-kind: Requirement
-display: table
-columns: name, layer
-sort: name
-empty: "No software requirements to trace."
-\`\`\`
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,Zi=`---
-id: sw-traceability
-title: Software Traceability Matrix
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["5.1.1", "5.7.5"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Software Traceability Matrix demonstrates bidirectional traceability from system requirements through software requirements, design, implementation, and test for **{{project.product}}**.
----
-## 2. Traceability Summary
-The following metric is computed live from the model:
-\`\`\`memo-query
-kind: Requirement
-display: count
-label: System requirements
-\`\`\`
-\`\`\`memo-query
-kind: Requirement
-display: count
-label: Software requirements
-\`\`\`
-\`\`\`memo-query
-kind: TestCase
-display: count
-label: Test cases
-\`\`\`
----
-## 3. System → Software Requirements
-This section is generated from the system model. The table below lists the **System → Software Requirements** elements currently defined:
-\`\`\`memo-query
-kind: Requirement
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No system requirements defined."
-\`\`\`
----
-## 4. Software Requirements
-This section is generated from the system model. The table below lists the **Software Requirements** elements currently defined:
-\`\`\`memo-query
-kind: Requirement
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No software requirements defined."
-\`\`\`
----
-## 5. Software Requirements → Design Elements
-This section is generated from the system model. The table below lists the **Software Requirements → Design Elements** elements currently defined:
-\`\`\`memo-query
-kind: [SoftwareItem, SoftwareUnit]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No software design elements defined."
-\`\`\`
----
-## 6. Test Cases
-This section is generated from the system model. The table below lists the **Test Cases** elements currently defined:
-\`\`\`memo-query
-kind: TestCase
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No test cases defined. Add TestCase elements."
-\`\`\`
----
-## 7. Untraced Requirements
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: List any software requirements without corresponding test cases]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,ea=`---
-id: system-test
-title: Software System Test Plan
-standard: IEC 62304:2006+AMD1:2015
-clauses: ["5.7"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This System Test Plan defines the approach for system-level testing of **{{project.product}}** per IEC 62304:2006 §5.7.
----
-## 2. System Requirements Under Test
-This section is generated from the system model. The table below lists the **System Requirements Under Test** elements currently defined:
-\`\`\`memo-query
-kind: Requirement
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No system requirements defined."
-\`\`\`
----
-## 3. System Test Cases
-This section is generated from the system model. The table below lists the **System Test Cases** elements currently defined:
-\`\`\`memo-query
-kind: [TestCase, ValidationActivity]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No system test cases defined."
-\`\`\`
----
-## 4. Test Environment
-Describe the hardware, software, tools, and configuration of the test environment in sufficient detail to reproduce the test setup.
-_[TODO: Describe the test environment, tools, and hardware configuration]_
----
-## 5. Anomaly Reporting
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe how test failures and anomalies are documented and tracked]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,ta=`---
-id: formative-eval
-title: Formative Usability Evaluation Report
-standard: IEC 62366-1:2015+AMD1:2020
-clauses: ["5.7"]
-required_for: ["CE", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-Documents formative (iterative) usability evaluation activities for **{{project.product}}** during design development.
----
-## 2. Evaluation Methods Used
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe methods used — expert review, cognitive walkthrough, prototype testing, etc.]_
----
-## 3. Issues Identified and Resolved
-Complete the table below for **{{project.product}}**:
-| Issue | Severity | Resolution | Status |
-| --- | --- | --- | --- |
-| | | | |
----
-## 4. Design Changes Made
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Summarize user interface design changes made as a result of formative evaluations]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,na=`---
-id: summative-eval
-title: Summative Usability Evaluation Report
-standard: IEC 62366-1:2015+AMD1:2020
-clauses: ["5.9"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This report documents the results of summative (validation) usability testing for **{{project.product}}** per IEC 62366-1:2015 §5.9.
----
-## 2. Test Participants
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe participant demographics, number, and selection criteria]_
----
-## 3. Test Scenarios
-This section is generated from the system model. The table below lists the **Test Scenarios** elements currently defined:
-\`\`\`memo-query
-kind: [UseCase, ValidationActivity]
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No validation scenarios defined."
-\`\`\`
----
-## 4. Results
-### 4.1 Task Completion Rates
-_[TODO: Report task completion rates and time-on-task for each critical task]_
-### 4.2 Use Errors Observed
-_[TODO: List all use errors observed during testing]_
-### 4.3 Pass/Fail Assessment
-_[TODO: State whether each test scenario passed or failed per pre-defined criteria]_
----
-## 5. Conclusions
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: State whether the device passed summative usability evaluation]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,ra=`---
-id: task-analysis
-title: Task Analysis
-standard: IEC 62366-1:2015+AMD1:2020
-clauses: ["5.4"]
-required_for: ["CE", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-Documents task analysis for **{{project.product}}** per IEC 62366-1:2015 §5.4, identifying tasks that could cause hazardous situations if performed incorrectly.
----
-## 2. User Tasks
-This section is generated from the system model. The table below lists the **User Tasks** elements currently defined:
-\`\`\`memo-query
-kind: UserActivity
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No UserActivity elements defined."
-\`\`\`
----
-## 3. Critical Tasks
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Identify which tasks are critical (could lead to hazardous situation if performed incorrectly)]_
-| Task | Critical | Hazardous Situation if Error | Mitigation |
-| --- | --- | --- | --- |
-| | | | |
----
-## 4. Task Flow Analysis
-The diagram below is rendered from the corresponding model view and reflects the current state of the model:
-{{diagram:task-flow}}
-_[TODO: Document sequential and parallel task flows with decision points]_
----
-{{include:shared/snippets/revision-history-table.md}}
-`,oa=`---
-id: ue-plan
-title: Usability Engineering Plan
-standard: IEC 62366-1:2015+AMD1:2020
-clauses: ["4"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Usability Engineering Plan (UE Plan) defines the usability engineering activities for **{{project.product}}** per IEC 62366-1:2015.
----
-## 2. Intended Users
-Identify every intended user group of **{{project.product}}**, including their roles, training assumptions, and use environments.
-_[TODO: Define all intended user groups (clinicians, patients, technicians, lay users)]_
----
-## 3. Intended Use Environment
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe all use environments: clinical, home, ambulatory, etc.]_
----
-## 4. Use-Related Hazards
-This section is generated from the system model. The table below lists the **Use-Related Hazards** elements currently defined:
-\`\`\`memo-query
-kind: [UseCase, UserActivity]
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No use cases or user activities defined."
-\`\`\`
----
-## 5. Usability Testing Plan
-### 5.1 Formative Evaluation
-_[TODO: Describe formative evaluation approach: cognitive walkthrough, expert review, prototype testing]_
-### 5.2 Summative Evaluation
-_[TODO: Describe summative usability testing: participants, scenarios, pass/fail criteria]_
----
-## 6. User Interface Elements
-This section is generated from the system model. The table below lists the **User Interface Elements** elements currently defined:
-\`\`\`memo-query
-kind: UserInterface
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No UserInterface elements defined."
-\`\`\`
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,sa=`---
-id: ui-spec
-title: User Interface Specification
-standard: IEC 62366-1:2015+AMD1:2020
-clauses: ["5.6"]
-required_for: ["CE", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-Specifies the user interface design for **{{project.product}}** per IEC 62366-1:2015 §5.6.
----
-## 2. User Interface Elements
-This section is generated from the system model. The table below lists the **User Interface Elements** elements currently defined:
-\`\`\`memo-query
-kind: UserInterface
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No UserInterface elements defined."
-\`\`\`
----
-## 3. Screen/Mode Specifications
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Document each screen, mode, and key interaction with screenshots or wireframes]_
----
-## 4. Alerts and Alarms
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Document all alarms, alerts, and status indicators with their visual/auditory characteristics]_
----
-## 5. Labeling on Device
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Document all labels, symbols, and icons used on the physical device]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,ia=`---
-id: urra
-title: Use-Related Risk Analysis
-standard: IEC 62366-1:2015+AMD1:2020
-clauses: ["5"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Use-Related Risk Analysis (URRA) identifies use errors and use-related hazardous situations for **{{project.product}}** per IEC 62366-1:2015 §5.
----
-## 2. Use Scenarios
-This section is generated from the system model. The table below lists the **Use Scenarios** elements currently defined:
-\`\`\`memo-query
-kind: [UseCase, UserActivity]
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No use scenarios defined. Add UseCase or UserActivity elements."
-\`\`\`
----
-## 3. Use Errors and Abnormal Use
-This section is generated from the system model. The table below lists the **Use Errors and Abnormal Use** elements currently defined:
-\`\`\`memo-query
-kind: [Hazard, HazardousSituation]
-where: layer == "ui"
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No use-related hazards defined."
-\`\`\`
----
-## 4. Critical Tasks
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Identify the critical tasks whose failure could cause a hazardous situation]_
----
-## 5. Mitigation Measures
-This section is generated from the system model. The table below lists the **Mitigation Measures** elements currently defined:
-\`\`\`memo-query
-kind: [RiskControlMeasure, UsabilityRequirement]
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No usability-related risk controls defined."
-\`\`\`
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,aa=`---
-id: use-spec
-title: Intended Use and Indications for Use Specification
-standard: IEC 62366-1:2015+AMD1:2020
-clauses: ["5.1"]
-required_for: ["CE", "FDA_510k", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Intended Use
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Provide the FDA-required Indications for Use statement and intended use statement]_
----
-## 2. Intended User Profile
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe user knowledge, training level, and physical/cognitive capabilities]_
----
-## 3. Use Environment
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe physical, social, technical environments where the device will be used]_
----
-## 4. Use Cases
-Use cases describing how intended users interact with **{{project.product}}**, drawn from the model:
-\`\`\`memo-query
-kind: UseCase
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No UseCase elements defined."
-\`\`\`
----
-## 5. Known Use-Related Constraints
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe contraindications, limitations, and warnings that constrain use]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,la=`---
-id: fmea
-title: Failure Mode and Effects Analysis
-standard: IEC 60812:2018
-clauses: ["5", "6", "7"]
-required_for: ["CE", "FDA_510k", "FDA_PMA"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose and Scope
-This FMEA documents failure modes for **{{project.product}}** components, their effects, severity, and mitigations. Combines hardware, software, and system-level failure analysis.
----
-## 2. Component Inventory
-This section is generated from the system model. The table below lists the **Component Inventory** elements currently defined:
-\`\`\`memo-query
-kind: [Component, Subsystem, SoftwareItem]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No components defined. Add Component, Subsystem, or SoftwareItem elements."
-\`\`\`
----
-## 3. FMEA Worksheet
-### 3.1 Hardware Failures
-\`\`\`memo-query
-kind: Component
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No hardware components defined."
-\`\`\`
-### 3.2 Software Failures
-\`\`\`memo-query
-kind: [SoftwareItem, SoftwareUnit]
-display: table
-columns: name, kind, layer, doc
-sort: name
-empty: "No software items defined."
-\`\`\`
-### 3.3 Interface Failures
-\`\`\`memo-query
-kind: Interface
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No interfaces defined."
-\`\`\`
----
-## 4. Risk Controls for FMEA Items
-This section is generated from the system model. The table below lists the **Risk Controls for FMEA Items** elements currently defined:
-\`\`\`memo-query
-kind: RiskControlMeasure
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No risk controls defined."
-\`\`\`
----
-## 5. Unmitigated Failures
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: List any failure modes without risk controls and justify residual risk]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,ca=`---
-id: fta
-title: Fault Tree Analysis
-standard: ISO 14971:2019
-clauses: ["5", "6"]
-required_for: ["CE"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Fault Tree Analysis (FTA) complements the FMEA by providing a top-down analysis of failure modes that could lead to identified harms for **{{project.product}}**.
----
-## 2. Top Events (Harms)
-This section is generated from the system model. The table below lists the **Top Events (Harms)** elements currently defined:
-\`\`\`memo-query
-kind: Harm
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No harm elements defined. Add Harm elements to the model."
-\`\`\`
----
-## 3. Contributing Failure Modes
-This section is generated from the system model. The table below lists the **Contributing Failure Modes** elements currently defined:
-\`\`\`memo-query
-kind: [Hazard, HazardousSituation]
-display: grouped
-group_by: layer
-columns: name, kind, doc
-sort: name
-empty: "No hazards or hazardous situations defined."
-\`\`\`
----
-## 4. Fault Tree Diagrams
-The diagram below is rendered from the corresponding model view and reflects the current state of the model:
-{{diagram:fta-diagram}}
-_[TODO: Attach or reference FTA diagram files]_
----
-## 5. Cut Sets and Recommendations
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: List minimal cut sets and associated risk reduction recommendations]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,da=`---
-id: har
-title: Hazard Analysis Report
-standard: ISO 14971:2019
-clauses: ["5", "6", "7"]
-required_for: ["CE", "FDA_510k", "FDA_PMA", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Hazard Analysis Report documents the systematic identification of hazards, hazardous situations, and harms associated with **{{project.product}}**, along with the associated risk estimation and risk control measures.
----
-## 2. Hazard Summary
-The following metric is computed live from the model:
-\`\`\`memo-query
-kind: Hazard
-display: count
-label: Total hazards identified
-\`\`\`
-\`\`\`memo-query
-kind: HazardousSituation
-display: count
-label: Hazardous situations
-\`\`\`
-\`\`\`memo-query
-kind: RiskControlMeasure
-display: count
-label: Risk control measures
-\`\`\`
----
-## 3. Hazard Identification
-All foreseeable hazards arising from the device, its intended use, and reasonably foreseeable misuse are listed below.
-### 3.1 Energy Hazards
-\`\`\`memo-query
-kind: Hazard
-where: doc contains "energy"
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No energy hazards identified."
-\`\`\`
-### 3.2 Biological and Chemical Hazards
-\`\`\`memo-query
-kind: Hazard
-where: doc contains "biolog"
-display: table
-columns: name, doc, layer
-empty: "No biological/chemical hazards identified."
-\`\`\`
-### 3.3 Operational Hazards
-\`\`\`memo-query
-kind: Hazard
-display: grouped
-group_by: layer
-columns: name, doc
-sort: name
-empty: "No hazards defined. Add Hazard elements to model/risk/*.sysml."
-\`\`\`
----
-## 4. Hazardous Situations
-This section is generated from the system model. The table below lists the **Hazardous Situations** elements currently defined:
-\`\`\`memo-query
-kind: HazardousSituation
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No hazardous situations defined. Add HazardousSituation elements."
-\`\`\`
----
-## 5. Risk Estimation
-<!-- [GUIDANCE] For each hazardous situation, estimate probability of occurrence and severity of harm per ISO 14971:2019 §5. -->
-\`\`\`memo-query
-kind: Harm
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No harm elements defined. Add Harm elements linked to HazardousSituation."
-\`\`\`
----
-## 6. Risk Control Measures
-### 6.1 Inherent Safety by Design
-\`\`\`memo-query
-kind: RiskControlMeasure
-where: doc contains "design"
-display: table
-columns: name, doc, layer
-empty: "No inherent safety controls."
-\`\`\`
-### 6.2 Protective Measures
-\`\`\`memo-query
-kind: RiskControlMeasure
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No risk controls defined. Add RiskControlMeasure elements."
-\`\`\`
-### 6.3 Information for Safety
-_[TODO: List all warnings, cautions, and contraindications in labeling]_
----
-## 7. Residual Risk Evaluation
-This section is generated from the system model. The table below lists the **Residual Risk Evaluation** elements currently defined:
-\`\`\`memo-query
-kind: Hazard
-display: table
-columns: name, layer, doc
-sort: name
-empty: "All hazards have been evaluated."
-\`\`\`
----
-## 8. Benefit-Risk Analysis
-<!-- [GUIDANCE] Per ISO 14971:2019 §8, if residual risks remain after all control measures, the overall residual risk must be judged acceptable relative to medical benefits. -->
-_[TODO: Document benefit-risk justification if any residual risks remain]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,ua=`---
-id: risk-benefit
-title: Risk-Benefit Analysis
-standard: ISO 14971:2019
-clauses: ["8"]
-required_for: ["CE", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## 1. Purpose
-This document provides the benefit-risk analysis for **{{project.product}}** as required by ISO 14971:2019 §8. It is prepared when residual risks cannot be further reduced and a judgment of acceptability must be made.
----
-## 2. Medical Benefits
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: Describe the medical benefits of the device for its intended patient population]_
----
-## 3. Residual Risks Summary
-This section is generated from the system model. The table below lists the **Residual Risks Summary** elements currently defined:
-\`\`\`memo-query
-kind: Hazard
-display: table
-columns: name, doc, layer
-sort: name
-empty: "No residual risks identified — standard risk controls are sufficient."
-\`\`\`
----
-## 4. Benefit-Risk Conclusion
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: State the conclusion: the medical benefits of the intended use outweigh the residual risks]_
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-`,pa=`---
-id: risk-matrix
-title: Risk Matrix
-standard: ISO 14971:2019
-clauses: ["5", "6"]
-required_for: ["CE", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
----
-## Risk Matrix
-This matrix shows the distribution of identified hazards across severity and probability levels.
-\`\`\`memo-query
-kind: Hazard
-display: matrix
-row_kind: kind
-col_kind: layer
-empty: "No hazards defined."
-\`\`\`
-### Hazard Coverage by Layer
-\`\`\`memo-query
-kind: [Hazard, HazardousSituation, Harm]
-display: grouped
-group_by: layer
-columns: name, kind, doc
-empty: "No risk elements defined."
-\`\`\`
----
-## Risk Control Coverage
-This section is generated from the system model. The table below lists the **Risk Control Coverage** elements currently defined:
-\`\`\`memo-query
-kind: RiskControlMeasure
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No risk controls defined."
-\`\`\`
----
-{{include:shared/snippets/revision-history-table.md}}
-`,ma=`---
-id: rmp
-title: Risk Management Plan
-standard: ISO 14971:2019
-clauses: ["4.4"]
-required_for: ["CE", "FDA_510k", "FDA_PMA", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose and Scope
-This Risk Management Plan (RMP) defines the risk management activities for **{{project.product}}** developed by **{{project.company}}**. This plan is maintained throughout the product lifecycle in accordance with ISO 14971:2019.
-### 1.1 Intended Use
-<!-- [GUIDANCE] Describe the intended use of the device, intended users, and intended use environment. -->
-_[TODO: Describe intended use, intended users, and intended use environment]_
-### 1.2 Scope of Risk Management
-This plan applies to all phases of the product lifecycle: design, development, manufacture, post-market surveillance, and eventual decommission.
----
-## 2. Regulatory Context
-Complete the table below for **{{project.product}}**:
-| Requirement | Reference |
-| --- | --- |
-| Risk Management Process | ISO 14971:2019 §4.1 |
-| Risk Management Plan | ISO 14971:2019 §4.4 |
-| Risk Estimation | ISO 14971:2019 §5 |
-| Risk Evaluation | ISO 14971:2019 §6 |
-| Risk Control | ISO 14971:2019 §7 |
-| Overall Residual Risk | ISO 14971:2019 §8 |
-| Risk Management Review | ISO 14971:2019 §9 |
-| Post-production | ISO 14971:2019 §10 |
----
-## 3. Risk Management Team
-<!-- [GUIDANCE] List all personnel involved in risk management activities. -->
-| Role | Name | Responsibilities |
-| --- | --- | --- |
-| Risk Management Lead | | Overall RM coordination |
-| Clinical Representative | | Clinical risk input |
-| Software Engineer | | Software FMEA and SOUP risk |
-| Regulatory Affairs | | Standards compliance |
-| Quality Engineer | | Process compliance |
----
-## 4. Risk Acceptability Criteria
-### 4.1 Severity Levels
-\`\`\`memo-query
-kind: RiskAcceptabilityCriteria
-display: table
-columns: name, doc, layer
-empty: "No risk acceptability criteria defined. Add RiskAcceptabilityCriteria elements to the model."
-\`\`\`
-### 4.2 Risk Policy
-<!-- [GUIDANCE] Define the risk policy: ALARP, broadly acceptable, or unacceptable regions. -->
-_[TODO: Define risk acceptability matrix — probability vs. severity]_
-Residual risk is acceptable when:
-- All individual risks are reduced to ALARP or broadly acceptable level
-- Overall residual risk is acceptable per §8 of ISO 14971:2019
-- Unmitigated hazards:
-\`\`\`memo-query
-kind: Hazard
-where: layer == "risk"
-display: count
-label: Total hazards in model
-\`\`\`
----
-## 5. Risk Management Activities
-### 5.1 Hazard Identification
-All hazard identification activities are documented in the Hazard Analysis Report (HAR).
-\`\`\`memo-query
-kind: Hazard
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No hazards defined. Add Hazard elements to model/risk/*.sysml."
-\`\`\`
-### 5.2 Risk Estimation and Evaluation
-Risk estimation is performed for each hazardous situation per ISO 14971:2019 §5–6.
-\`\`\`memo-query
-kind: HazardousSituation
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No hazardous situations defined."
-\`\`\`
-### 5.3 Risk Control Measures
-\`\`\`memo-query
-kind: RiskControlMeasure
-display: table
-columns: name, layer, doc
-sort: name
-empty: "No risk controls defined."
-\`\`\`
-### 5.4 Residual Risk Evaluation
-Unmitigated hazards (hazards without associated risk controls):
-\`\`\`memo-query
-kind: Hazard
-display: table
-columns: name, doc
-empty: "All hazards have associated risk controls."
-\`\`\`
----
-## 6. Risk Management Documentation
-Complete the table below for **{{project.product}}**:
-| Document | Purpose | Reference |
-| --- | --- | --- |
-| Hazard Analysis Report (HAR) | Hazard identification and estimation | HAR |
-| FMEA | Failure mode analysis | FMEA |
-| Risk Benefit Analysis | Benefit-risk justification | N/A |
-| Risk Management Report | Overall residual risk summary | N/A |
----
-## 7. Plan Maintenance
-This plan shall be reviewed:
-- At each major design change
-- Following post-market surveillance findings
-- Prior to each design review gate
-- At least annually during active development
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,fa=`---
-id: rmr
-title: Risk Management Report
-standard: ISO 14971:2019
-clauses: ["9"]
-required_for: ["CE", "FDA_510k", "FDA_PMA", "MDR"]
----
-{{include:shared/snippets/document-control-header.md}}
-{{toc}}
----
-## 1. Purpose
-This Risk Management Report (RMR) summarizes the results of all risk management activities performed for **{{project.product}}** in accordance with ISO 14971:2019 §9.
----
-## 2. Summary Statistics
-The following metric is computed live from the model:
-\`\`\`memo-query
-kind: Hazard
-display: count
-label: Total hazards identified
-\`\`\`
-\`\`\`memo-query
-kind: RiskControlMeasure
-display: count
-label: Risk controls implemented
-\`\`\`
-\`\`\`memo-query
-kind: HazardousSituation
-display: count
-label: Hazardous situations analyzed
-\`\`\`
----
-## 3. Risk Management Plan Compliance
-<!-- [GUIDANCE] Confirm that the risk management plan was executed as documented. -->
-_[TODO: Confirm that all activities in the Risk Management Plan were completed]_
-| Activity | Status | Reference |
-| --- | --- | --- |
-| Hazard identification | | HAR |
-| Risk estimation | | HAR |
-| Risk evaluation | | HAR |
-| Risk control implementation | | Design records |
-| Residual risk evaluation | | HAR |
-| Overall residual risk | | This document |
-| Post-production monitoring | | Post-Market Surveillance Plan |
----
-## 4. Overall Residual Risk Evaluation
-### 4.1 Remaining Hazards
-\`\`\`memo-query
-kind: Hazard
-display: table
-columns: name, layer, doc
-sort: name
-empty: "All identified hazards have been evaluated."
-\`\`\`
-### 4.2 Overall Residual Risk Conclusion
-<!-- [GUIDANCE] Conclude whether the overall residual risk is acceptable relative to the medical benefits of the device. -->
-_[TODO: State the overall residual risk conclusion with justification]_
----
-## 5. Benefit-Risk Statement
-Complete this section for **{{project.product}}** using the guidance below.
-_[TODO: State clearly that the benefits of the device outweigh the residual risks for the intended use]_
----
-## 6. Post-Production Information Collection
-Post-production information collection activities are documented in the Post-Market Surveillance Plan.
----
-{{include:shared/snippets/revision-history-table.md}}
-{{include:shared/snippets/approval-block.md}}
-{{include:shared/snippets/references-section.md}}
-`,ha=`---
-id: approval-block
-title: Approval Block
----
-## Approvals
-This document has been reviewed and approved by the following personnel:
-| Name | Role | Signature | Date |
-| --- | --- | --- | --- |
-| | Quality Assurance | | |
-| | Regulatory Affairs | | |
-| | Engineering Lead | | |
-| | Clinical Affairs | | |
-`,ga=`---
-id: document-control-header
-title: Document Control Header
----
-| Field | Value |
-| --- | --- |
-| **Product** | {{project.product}} |
-| **Company** | {{project.company}} |
-| **Device Type** | {{project.device_type}} |
-| **Document Version** | {{project.version}} |
-| **Development Phase** | {{project.phase}} |
-| **Date** | — |
-| **Confidentiality** | Confidential — {{project.company}} |
-`,ya=`---
-id: references-section
-title: References
----
-## References
-| Standard | Title |
-| --- | --- |
-| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
-| IEC 62304:2006+AMD1:2015 | Medical device software — Software life cycle processes |
-| IEC 62366-1:2015+AMD1:2020 | Medical devices — Usability engineering |
-| ISO 13485:2016 | Medical devices — Quality management systems |
-| 21 CFR Part 820 | Quality System Regulation |
-| IEC 81001-5-1:2021 | Health software and health IT systems safety, effectiveness and security |
-`,xa=`---
-id: revision-history-table
-title: Revision History Table
----
-## Revision History
-| Version | Date | Author | Description of Change |
-| --- | --- | --- | --- |
-| 1.0 | {{project.version}} | {{project.authors}} | Initial release |
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