@memoarchitect/ontology 0.4.4

package/src/compliance/dhf-templates/iso-14971/fmea.md

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+---
+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: RiskControl
+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}}

package/src/compliance/dhf-templates/iso-14971/fta.md

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+---
+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}}

package/src/compliance/dhf-templates/iso-14971/har.md

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+---
+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: RiskControl
+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: RiskControl
+where: doc contains "design"
+display: table
+columns: name, doc, layer
+empty: "No inherent safety controls."
+```
+
+### 6.2 Protective Measures
+
+```memo-query
+kind: RiskControl
+display: table
+columns: name, doc, layer
+sort: name
+empty: "No risk controls defined. Add RiskControl 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}}

package/src/compliance/dhf-templates/iso-14971/risk-benefit.md

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+---
+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}}

package/src/compliance/dhf-templates/iso-14971/risk-matrix.md

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+---
+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: RiskControl
+display: table
+columns: name, layer, doc
+sort: name
+empty: "No risk controls defined."
+```
+
+---
+
+{{include:shared/snippets/revision-history-table.md}}

package/src/compliance/dhf-templates/iso-14971/rmp.md

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+---
+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: RiskControl
+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}}

package/src/compliance/dhf-templates/iso-14971/rmr.md

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+---
+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: RiskControl
+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}}

package/src/compliance/dhf-templates/shared/snippets/approval-block.md

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+---
+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 | | |
+