@memoarchitect/ontology 0.4.4

package/src/compliance/dhf-templates/iec-62304/change-control.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62304/detailed-design.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62304/integration-test.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62304/sad.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62304/sbom.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62304/sdp.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62304/soup.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62304/srs.md

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+---
+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}}