@memoarchitect/ontology 0.4.4

package/src/artifacts/requirements_traceability_matrix.sysml

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+package memo_artifacts_requirements_traceability_matrix {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def RequirementsTraceabilityMatrix specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Requirements Traceability Matrix";
+    attribute :>> regulatoryRef = "IEC 62304:2006 §5.1.1";
+    attribute :>> artifactKind = ArtifactKind::traceMatrix;
+            }
+}

package/src/artifacts/risk_management_plan.sysml

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+package memo_artifacts_risk_management_plan {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def RiskManagementPlan specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Risk Management Plan";
+    attribute :>> regulatoryRef = "ISO 14971:2019 §4.4";
+    attribute :>> artifactKind = ArtifactKind::plan;
+            }
+}

package/src/artifacts/software_design_description.sysml

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+package memo_artifacts_software_design_description {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def SoftwareDesignDescription specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Software Design Description";
+    attribute :>> regulatoryRef = "IEC 62304:2006 §5.4";
+    attribute :>> artifactKind = ArtifactKind::softwareDesignDescription;
+            }
+}

package/src/artifacts/software_development_plan.sysml

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+package memo_artifacts_software_development_plan {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def SoftwareDevelopmentPlan specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Software Development Plan";
+    attribute :>> regulatoryRef = "IEC 62304:2006 §5.1";
+    attribute :>> artifactKind = ArtifactKind::softwareDevelopmentPlan;
+            }
+}

package/src/artifacts/soup_list.sysml

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+package memo_artifacts_soup_list {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def SoupList specializes ArtifactKindDef {
+    attribute :>> documentTitle = "SOUP List (Software of Unknown Provenance)";
+    attribute :>> regulatoryRef = "IEC 62304:2006 §8.1.2";
+    attribute :>> artifactKind = ArtifactKind::soupList;
+            }
+}

package/src/artifacts/system_architecture_description.sysml

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+package memo_artifacts_system_architecture_description {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def SystemArchitectureDescription specializes ArtifactKindDef {
+    attribute :>> documentTitle = "System Architecture Description";
+    attribute :>> regulatoryRef = "ISO/IEC/IEEE 42010:2022";
+    attribute :>> artifactKind = ArtifactKind::architectureDescription;
+            }
+}

package/src/artifacts/test_protocol.sysml

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+package memo_artifacts_test_protocol {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def TestProtocol specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Test Protocol";
+    attribute :>> regulatoryRef = "ISO 13485:2016 §7.3.6";
+    attribute :>> artifactKind = ArtifactKind::testProtocol;
+            }
+}

package/src/artifacts/test_report.sysml

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+package memo_artifacts_test_report {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def TestReport specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Test Report";
+    attribute :>> regulatoryRef = "ISO 13485:2016 §7.3.7";
+    attribute :>> artifactKind = ArtifactKind::testReport;
+            }
+}

package/src/artifacts/threat_model_report.sysml

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+package memo_artifacts_threat_model_report {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def ThreatModelReport specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Threat Model";
+    attribute :>> regulatoryRef = "IEC 81001-5-1:2021";
+    attribute :>> artifactKind = ArtifactKind::threatModel;
+            }
+}

package/src/artifacts/usability_engineering_report.sysml

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+package memo_artifacts_usability_engineering_report {
+    private import ScalarValues::*;
+
+            private import memo_artifacts_definitions::*;
+            private import memo_core_enumerations::*;
+
+            part def UsabilityEngineeringReport specializes ArtifactKindDef {
+    attribute :>> documentTitle = "Usability Engineering Report";
+    attribute :>> regulatoryRef = "IEC 62366-1:2015";
+    attribute :>> artifactKind = ArtifactKind::usabilityEngineeringReport;
+            }
+}

package/src/compliance/artifacts/memo_artifacts.sysml

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+package memo_compliance_artifacts {
+    private import ScalarValues::*;
+
+    private import memo_core_common::*;
+    private import memo_core_enumerations::*;
+    item def ControlledArtifact specializes TraceableElement {
+        attribute version : String;
+        attribute lifecycleState : LifecycleStateKind;
+        attribute artifactKind : ArtifactKind;
+        attribute owner : String;
+        attribute approvalStatus : String;
+    }
+}

package/src/compliance/change/memo_change.sysml

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+package memo_compliance_change {
+    private import ScalarValues::*;
+
+    private import memo_core_common::*;
+    private import memo_core_enumerations::*;
+    part def ChangeRequest specializes TraceableElement {
+        attribute changeType : ChangeTypeKind;
+        attribute impactAssessment : String;
+        attribute approvalStatus : String;
+        attribute affectedBaseline : String;
+    }
+    part def ConfigurationItem specializes TraceableElement {
+        attribute version : String;
+        attribute baseline : String;
+        attribute controlLevel : String;
+    }
+}

package/src/compliance/dhf-templates/21cfr820/change-record.md

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+---
+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}}

package/src/compliance/dhf-templates/21cfr820/design-input.md

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+---
+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, StakeholderNeed]
+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}}

package/src/compliance/dhf-templates/21cfr820/design-output.md

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+---
+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}}

package/src/compliance/dhf-templates/21cfr820/design-review.md

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+---
+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}}

package/src/compliance/dhf-templates/21cfr820/design-validation.md

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+---
+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: [StakeholderNeed, 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}}

package/src/compliance/dhf-templates/21cfr820/design-verification.md

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+---
+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}}

package/src/compliance/dhf-templates/21cfr820/dhf-index.md

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+---
+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}}