@memoarchitect/ontology 0.6.5 → 0.8.22

package/src/compliance/artifacts/memo_artifacts.sysml

@@ -1,12 +0,0 @@
-package memo_compliance_artifacts {
-    private import ScalarValues::*;
-
-    private import memo_core_common::*;
-    private import memo_core_enumerations::*;
-    item def ControlledArtifact specializes MemoPart {
-        attribute version : String;
-        attribute artifactKind : ArtifactKind;
-        attribute owner : String;
-        attribute approvalStatus : String;
-    }
-}

package/src/compliance/change/memo_change.sysml

@@ -1,17 +0,0 @@
-package memo_compliance_change {
-    private import ScalarValues::*;
-
-    private import memo_core_common::*;
-    private import memo_core_enumerations::*;
-    part def ChangeRequest specializes MemoPart {
-        attribute changeType : ChangeTypeKind;
-        attribute impactAssessment : String;
-        attribute approvalStatus : String;
-        attribute affectedBaseline : String;
-    }
-    part def ConfigurationItem specializes MemoPart {
-        attribute version : String;
-        attribute baseline : String;
-        attribute controlLevel : String;
-    }
-}

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

@@ -1,138 +0,0 @@
----
-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}}

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

@@ -1,57 +0,0 @@
----
-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/iso-14971/fmea.md

@@ -1,93 +0,0 @@
----
-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: RiskControlMeasure
-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/document_views/memo_document_views.sysml

@@ -1,7 +0,0 @@
-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

@@ -1,16 +0,0 @@
-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 MemoPart {
-        attribute standardReference : String;
-        attribute clause : String;
-        attribute edition : String;
-        attribute completenessStatus : String;
-    }
-}

package/src/compliance/postmarket/memo_postmarket.sysml

@@ -1,16 +0,0 @@
-package memo_compliance_postmarket {
-    private import ScalarValues::*;
-
-    private import memo_core_common::*;
-    private import memo_core_enumerations::*;
-    part def ClinicalEvaluation specializes MemoPart {
-        attribute evaluationStage : String;
-        attribute clinicalDataSource : String;
-        attribute conclusion : String;
-    }
-    part def PostMarketSurveillance specializes MemoPart {
-        attribute surveillanceKind : String;
-        attribute dataSource : String;
-        attribute reportingObligation : String;
-    }
-}