@memoarchitect/ontology 0.4.4

package/src/compliance/dhf-templates/iec-62304/sw-traceability.md

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+---
+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}}

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

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+---
+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}}

package/src/compliance/dhf-templates/iec-62366/formative-eval.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62366/summative-eval.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62366/task-analysis.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62366/ue-plan.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62366/ui-spec.md

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+---
+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}}

package/src/compliance/dhf-templates/iec-62366/urra.md

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+---
+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: [RiskControl, 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}}

package/src/compliance/dhf-templates/iec-62366/use-spec.md

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+---
+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}}