@memoarchitect/ontology 0.4.4

package/src/compliance/dhf-templates/shared/snippets/document-control-header.md

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+---
+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}} |
+

package/src/compliance/dhf-templates/shared/snippets/references-section.md

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+---
+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 |
+

package/src/compliance/dhf-templates/shared/snippets/revision-history-table.md

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+---
+id: revision-history-table
+title: Revision History Table
+---
+
+## Revision History
+
+| Version | Date | Author | Description of Change |
+| --- | --- | --- | --- |
+| 1.0 | {{project.version}} | {{project.authors}} | Initial release |
+

package/src/compliance/document_views/memo_document_views.sysml

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+package memo_compliance_document_views {
+    private import ScalarValues::*;
+
+    public import memo_viewpoints_definitions::MemoDocumentView;
+    public import memo_viewpoints_cybersecurity_threat_model_view::MemoCybersecurityThreatModelView;
+    public import memo_viewpoints_cybersecurity_cybersecurity_assessment_view::MemoCybersecurityAssessmentView;
+}

package/src/compliance/iso14971/risk_management_file.sysml

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+package memo_compliance_iso14971 {
+    private import ScalarValues::*;
+
+    private import memo_core_common::*;
+    private import memo_core_enumerations::*;
+
+    doc /* ISO 14971 Risk Management File — the top-level deliverable
+           that aggregates all risk management artifacts required by
+           ISO 14971:2019 clause 4.5. */
+    part def RiskManagementFile specializes TraceableElement {
+        attribute standardReference : String;
+        attribute clause : String;
+        attribute edition : String;
+        attribute completenessStatus : String;
+    }
+}

package/src/compliance/postmarket/memo_postmarket.sysml

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+package memo_compliance_postmarket {
+    private import ScalarValues::*;
+
+    private import memo_core_common::*;
+    private import memo_core_enumerations::*;
+    part def ClinicalEvaluation specializes TraceableElement {
+        attribute evaluationStage : String;
+        attribute clinicalDataSource : String;
+        attribute conclusion : String;
+    }
+    part def PostMarketSurveillance specializes TraceableElement {
+        attribute surveillanceKind : String;
+        attribute dataSource : String;
+        attribute reportingObligation : String;
+    }
+}

package/src/core/common/memo_common.sysml

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+package memo_core_common {
+    private import ScalarValues::*;
+
+    private import memo_core_enumerations::*;
+
+    part def IdentifiedElement {
+        attribute id : String;
+        attribute name : String;
+        attribute description : String;
+    }
+
+    part def TraceableElement specializes IdentifiedElement {
+        attribute rationale : String;
+        attribute sourceReference : String;
+    }
+
+    part def DocumentedElement specializes TraceableElement {
+        attribute title : String;
+        attribute shortDescription : String;
+        attribute longDescription : String;
+        attribute documentUsage : String[*];
+        attribute sectionIdentifier : String;
+    }
+
+    part def RequirementDriver specializes TraceableElement;
+    part def VerifiableElement specializes TraceableElement;
+    part def ArchitectureElement specializes TraceableElement;
+    part def InterfaceElement specializes TraceableElement;
+    part def EvidenceElement specializes TraceableElement;
+
+    part def ExchangeItem specializes TraceableElement {
+        attribute semantics : String;
+        attribute unit : String;
+        attribute minValue : String;
+        attribute maxValue : String;
+        attribute encoding : String;
+        attribute timestampRequired : Boolean;
+    }
+
+    part def LayerElement specializes TraceableElement {
+        attribute layerName : String;
+    }
+
+    part def Citation specializes IdentifiedElement {
+        attribute source : String;
+        attribute section : String;
+        attribute uri : String;
+        attribute year : String;
+    }
+}

package/src/core/consistency_rules/consistency_rules.sysml

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+// Consistency rule base types per Epic N.
+// Bare imports (no `private`) per ADR-1-16 fallback.
+package memo_core_consistency_rules {
+    private import ScalarValues::*;
+
+    private import memo_core_common::*;
+    private import memo_core_enumerations::*;
+
+    part def ConsistencyRule specializes TraceableElement {
+        attribute appliesTo : String;
+        attribute predicate : RulePredicateKind;
+        attribute strength : RuleStrengthKind;
+        attribute severity : RuleSeverityKind;
+        attribute rationaleText : String;
+        attribute category : RuleCategoryKind;
+    }
+
+    part def RelationshipConsistencyRule specializes ConsistencyRule {
+        attribute relationshipType : String;
+        attribute minCount : String;
+        attribute maxCount : String;
+        attribute direction : String;
+        attribute relatedKinds : String;
+    }
+
+    part def AttributeConsistencyRule specializes ConsistencyRule {
+        attribute targetAttribute : String;
+    }
+
+    part def ConditionalConsistencyRule specializes RelationshipConsistencyRule {
+        attribute conditionAttribute : String;
+        attribute conditionOperator : String;
+        attribute conditionValues : String;
+    }
+
+    part def CoverageConsistencyRule specializes ConsistencyRule {
+        attribute standardReference : String;
+        attribute clause : String;
+        attribute coverageTarget : String;
+    }
+}

package/src/core/dimensions/dimensions.sysml

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+// Multi-valued attributes collapsed to scalar pending grammar extension (ADR-1-16).
+// Bare import (no `private`) per ADR-1-16 fallback.
+package memo_core_dimensions {
+    private import ScalarValues::*;
+
+    private import memo_core_common::*;
+
+    enum def DimensionKind {
+        enum architecture;
+        enum compliance;
+        enum artifact;
+        enum viewpointType;
+    }
+
+    part def ElementKind specializes TraceableElement {
+        attribute kindName : String;
+        attribute primaryDimension : DimensionKind;
+    }
+
+    part def ArchitectureElementKind specializes ElementKind {
+        attribute archLayer : String;
+    }
+
+    part def ComplianceElementKind specializes ElementKind {
+        attribute standardReference : String;
+        attribute clause : String;
+    }
+
+    part def ArtifactElementKind specializes ElementKind {
+        attribute documentTitle : String;
+        attribute regulatoryReference : String;
+    }
+
+    part def ViewpointTypeKind specializes ElementKind {
+        attribute typeId : String;
+    }
+}