@memoarchitect/ontology 0.6.5 → 0.8.22

package/src/artifacts/standards/iec_81001_5_1.sysml

@@ -0,0 +1,84 @@
+// IEC 81001-5-1:2021 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
+//
+// Clause instances, not type machinery. Everything here is data: adding a
+// standard is one file like this one and zero TypeScript changes.
+package memo_artifacts_standards_iec_81001_5_1 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iec81001_5_1 : RegulatoryStandard {
+        attribute :>> id = "STD-IEC-81001-5-1";
+        attribute :>> name = "IEC81001_5_1";
+        attribute :>> designation = "IEC 81001-5-1:2021";
+        attribute :>> edition = "2021";
+        attribute :>> issuer = "IEC";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item iec81001_5_1Clause4 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-4";
+        attribute :>> name = "IEC81001_5_1Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general requirements";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5";
+        attribute :>> name = "IEC81001_5_1Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "software development process";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_1 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-1";
+        attribute :>> name = "IEC81001_5_1Clause5_1";
+        attribute :>> clauseNumber = "5.1";
+        attribute :>> title = "software development planning";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_2 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-2";
+        attribute :>> name = "IEC81001_5_1Clause5_2";
+        attribute :>> clauseNumber = "5.2";
+        attribute :>> title = "software requirements analysis";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_3 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-3";
+        attribute :>> name = "IEC81001_5_1Clause5_3";
+        attribute :>> clauseNumber = "5.3";
+        attribute :>> title = "software architectural design";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_4 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-4";
+        attribute :>> name = "IEC81001_5_1Clause5_4";
+        attribute :>> clauseNumber = "5.4";
+        attribute :>> title = "software design";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_8 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-8";
+        attribute :>> name = "IEC81001_5_1Clause5_8";
+        attribute :>> clauseNumber = "5.8";
+        attribute :>> title = "software release";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iec81001_5_1Has4 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause4;
+    connection iec81001_5_1Has5 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause5;
+    
+    connection iec81001_5_1Has5_1 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_1;
+    connection iec81001_5_1Has5_2 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_2;
+    connection iec81001_5_1Has5_3 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_3;
+    connection iec81001_5_1Has5_4 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_4;
+    connection iec81001_5_1Has5_8 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_8;
+}

package/src/artifacts/standards/iso_13485.sysml

@@ -0,0 +1,113 @@
+// ISO 13485:2016 — quality management systems for medical devices.
+//
+// Only the design-and-development and document-control clauses MEMO documents
+// actually claim are represented. The rest of the QMS is a management-system
+// concern that no model element traces to, and an unclaimed clause costs
+// nothing to add later.
+package memo_artifacts_standards_iso_13485 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iso13485 : RegulatoryStandard {
+        attribute :>> id = "STD-ISO-13485";
+        attribute :>> name = "ISO13485";
+        attribute :>> designation = "ISO 13485:2016";
+        attribute :>> edition = "2016";
+        attribute :>> issuer = "ISO";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA);
+    }
+
+    item iso13485Clause4 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-4";
+        attribute :>> name = "ISO13485Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "quality management system";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause4_2 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-4-2";
+        attribute :>> name = "ISO13485Clause4_2";
+        attribute :>> clauseNumber = "4.2";
+        attribute :>> title = "quality management system documentation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause4_2_4 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-4-2-4";
+        attribute :>> name = "ISO13485Clause4_2_4";
+        attribute :>> clauseNumber = "4.2.4";
+        attribute :>> title = "control of documents";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7";
+        attribute :>> name = "ISO13485Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> title = "product realization";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3";
+        attribute :>> name = "ISO13485Clause7_3";
+        attribute :>> clauseNumber = "7.3";
+        attribute :>> title = "design and development";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_3 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-3";
+        attribute :>> name = "ISO13485Clause7_3_3";
+        attribute :>> clauseNumber = "7.3.3";
+        attribute :>> title = "design and development inputs";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_4 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-4";
+        attribute :>> name = "ISO13485Clause7_3_4";
+        attribute :>> clauseNumber = "7.3.4";
+        attribute :>> title = "design and development outputs";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_6 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-6";
+        attribute :>> name = "ISO13485Clause7_3_6";
+        attribute :>> clauseNumber = "7.3.6";
+        attribute :>> title = "design and development verification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_7 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-7";
+        attribute :>> name = "ISO13485Clause7_3_7";
+        attribute :>> clauseNumber = "7.3.7";
+        attribute :>> title = "design and development validation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_9 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-9";
+        attribute :>> name = "ISO13485Clause7_3_9";
+        attribute :>> clauseNumber = "7.3.9";
+        attribute :>> title = "control of design and development changes";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_10 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-10";
+        attribute :>> name = "ISO13485Clause7_3_10";
+        attribute :>> clauseNumber = "7.3.10";
+        attribute :>> title = "design and development files";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iso13485Has4 : Composes connect parent ::> iso13485 to child ::> iso13485Clause4;
+    connection iso13485Has7 : Composes connect parent ::> iso13485 to child ::> iso13485Clause7;
+
+    connection iso13485Has4_2 : Composes connect parent ::> iso13485Clause4 to child ::> iso13485Clause4_2;
+    connection iso13485Has4_2_4 : Composes connect parent ::> iso13485Clause4_2 to child ::> iso13485Clause4_2_4;
+
+    connection iso13485Has7_3 : Composes connect parent ::> iso13485Clause7 to child ::> iso13485Clause7_3;
+    connection iso13485Has7_3_3 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_3;
+    connection iso13485Has7_3_4 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_4;
+    connection iso13485Has7_3_6 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_6;
+    connection iso13485Has7_3_7 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_7;
+    connection iso13485Has7_3_9 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_9;
+    connection iso13485Has7_3_10 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_10;
+}

package/src/artifacts/standards/iso_14971.sysml

@@ -0,0 +1,94 @@
+// ISO 14971:2019 — application of risk management to medical devices.
+//
+// The risk-management process every other pack feeds. `title` is a
+// MEMO-AUTHORED scope phrase, never the standard's own normative wording.
+package memo_artifacts_standards_iso_14971 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iso14971 : RegulatoryStandard {
+        attribute :>> id = "STD-ISO-14971";
+        attribute :>> name = "ISO14971";
+        attribute :>> designation = "ISO 14971:2019";
+        attribute :>> edition = "2019";
+        attribute :>> issuer = "ISO";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item iso14971Clause4 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-4";
+        attribute :>> name = "ISO14971Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general requirements for the risk management system";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause4_4 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-4-4";
+        attribute :>> name = "ISO14971Clause4_4";
+        attribute :>> clauseNumber = "4.4";
+        attribute :>> title = "risk management plan";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause4_5 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-4-5";
+        attribute :>> name = "ISO14971Clause4_5";
+        attribute :>> clauseNumber = "4.5";
+        attribute :>> title = "risk management file";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause5 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-5";
+        attribute :>> name = "ISO14971Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "risk analysis";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause6 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-6";
+        attribute :>> name = "ISO14971Clause6";
+        attribute :>> clauseNumber = "6";
+        attribute :>> title = "risk evaluation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause7 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-7";
+        attribute :>> name = "ISO14971Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> title = "risk control";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause8 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-8";
+        attribute :>> name = "ISO14971Clause8";
+        attribute :>> clauseNumber = "8";
+        attribute :>> title = "evaluation of overall residual risk";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause9 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-9";
+        attribute :>> name = "ISO14971Clause9";
+        attribute :>> clauseNumber = "9";
+        attribute :>> title = "risk management review";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause10 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-10";
+        attribute :>> name = "ISO14971Clause10";
+        attribute :>> clauseNumber = "10";
+        attribute :>> title = "production and post-production activities";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iso14971Has4 : Composes connect parent ::> iso14971 to child ::> iso14971Clause4;
+    connection iso14971Has5 : Composes connect parent ::> iso14971 to child ::> iso14971Clause5;
+    connection iso14971Has6 : Composes connect parent ::> iso14971 to child ::> iso14971Clause6;
+    connection iso14971Has7 : Composes connect parent ::> iso14971 to child ::> iso14971Clause7;
+    connection iso14971Has8 : Composes connect parent ::> iso14971 to child ::> iso14971Clause8;
+    connection iso14971Has9 : Composes connect parent ::> iso14971 to child ::> iso14971Clause9;
+    connection iso14971Has10 : Composes connect parent ::> iso14971 to child ::> iso14971Clause10;
+
+    connection iso14971Has4_4 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_4;
+    connection iso14971Has4_5 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_5;
+}

package/src/artifacts/standards/iso_iec_ieee_42010.sysml

@@ -0,0 +1,42 @@
+// ISO/IEC/IEEE 42010:2022 — architecture description.
+//
+// One standard from a joint committee, not three: the spaced slash is what
+// separates two designations, and there is none here.
+//
+// SCOPE PHRASES DELIBERATELY ABSENT — same reason as the IEC 60812 pack. The
+// 2022 edition reorganised the clause structure of 42010:2011, and MEMO has no
+// verified reading of the new numbering. A missing label is a gap a reviewer
+// closes in one line; a guessed one is a citation nobody can check.
+package memo_artifacts_standards_iso_iec_ieee_42010 {
+    private import ScalarValues::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item isoIecIeee42010 : RegulatoryStandard {
+        attribute :>> id = "STD-ISO-IEC-IEEE-42010";
+        attribute :>> name = "ISOIECIEEE42010";
+        attribute :>> designation = "ISO/IEC/IEEE 42010:2022";
+        attribute :>> edition = "2022";
+        attribute :>> issuer = "ISO/IEC/IEEE";
+        // No submission regime mandates this standard: it is a method /
+        // reference standard, cited by documents rather than required by a
+        // market. Empty is the authored value, not an omission — see
+        // appliesToRegime in memo_artifacts_standards_traceability.
+    }
+
+    item isoIecIeee42010Clause5 : StandardClause {
+        attribute :>> id = "STD-ISO-IEC-IEEE-42010-5";
+        attribute :>> name = "ISOIECIEEE42010Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> normativeStrength = "shall";
+    }
+    item isoIecIeee42010Clause6 : StandardClause {
+        attribute :>> id = "STD-ISO-IEC-IEEE-42010-6";
+        attribute :>> name = "ISOIECIEEE42010Clause6";
+        attribute :>> clauseNumber = "6";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection isoIecIeee42010Has5 : Composes connect parent ::> isoIecIeee42010 to child ::> isoIecIeee42010Clause5;
+    connection isoIecIeee42010Has6 : Composes connect parent ::> isoIecIeee42010 to child ::> isoIecIeee42010Clause6;
+}

package/src/artifacts/standards/memo_artifacts_standards_traceability.sysml

@@ -0,0 +1,132 @@
+// Clause-level traceability: the project-facing half of the regulatory axis.
+//
+// MEMO carries standards in two mechanisms, and this file is one of them:
+//
+//   @StandardReference metadata (core/semantics)  — provenance INSIDE the MEMO
+//     library: "this ontology type exists because ISO 14971 §5.4 says so".
+//     Library-internal, not project data.
+//   ConformsTo (here)                             — PROJECT traceability:
+//     "this requirement in this project satisfies IEC 62304 §5.2.2".
+//     Queryable, reportable, auditable.
+//
+// Do not add a third. A standard is data in the ontology, not a code path:
+// adding ISO 13485 must be one new file of RegulatoryStandard/StandardClause
+// instances and zero TypeScript changes.
+//
+// Nothing here is abstract. An abstract def cannot be instantiated, so a
+// traceability matrix over abstract clause types is empty by construction —
+// which is the failure mode this whole area exists to prevent.
+//
+// ─── The clause library and how a document cites it ──────────────────────
+//
+// The concrete instances live one file per standard beside this one
+// (iec_62304.sysml, iec_60601_1.sysml, …). A DHF template cites them from its
+// frontmatter, in one of two shapes:
+//
+//   clauses: ["5.4"]                              relative — the clause number
+//                                                 belongs to this document's
+//                                                 own `standard:`
+//   clauses: ["ISO 14971:2019 §7"]                qualified — the designation
+//                                                 before the section sign, the
+//                                                 clause number after it
+//
+// An entry containing "§" is qualified and nothing else is: that is the whole
+// grammar. The designation must match a RegulatoryStandard's `designation`
+// exactly, amendments included, and the clause number must match a
+// StandardClause's `clauseNumber` exactly. Both are checked by
+// standards-library.test.ts in memo-tools, which is what makes "adding a
+// standard is one file" true rather than aspirational.
+package memo_artifacts_standards_traceability {
+    private import Metaobjects::SemanticMetadata;
+    private import ScalarValues::*;
+    private import memo_core_common::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_core::*;
+
+    // =========================================================================
+    // Standards and clauses
+    // =========================================================================
+
+    item def RegulatoryStandard :> MemoArtifactItem {
+        doc /* A regulatory or consensus standard a project claims conformance
+             * to, identified by its full designation including edition and
+             * amendments (e.g. "IEC 62366-1:2015+AMD1:2020"). Dropping the
+             * amendment is a CE/MDR regression, so it is carried explicitly
+             * rather than folded into the designation by convention. */
+        attribute designation : String;
+        attribute edition : String[0..1];
+        attribute issuer : String[0..1];
+        attribute amendments : String[0..*];
+        // Which submission regimes this standard has standing in. Empty is a
+        // MEANINGFUL value, not an unset one: it says no regime mandates this
+        // standard, which is true of the method and reference standards MEMO
+        // carries (IEC 60812's FMEA method, ISO/IEC/IEEE 42010's architecture
+        // description). A regime-free standard never contributes to
+        // `required(project)` — its clauses are claimable but not required.
+        //
+        // Because empty means something, it cannot also mean "the pack author
+        // forgot". `memo standards check` prints regime-free standards in their
+        // own section rather than dropping them, and standards-library.test.ts
+        // names the exact set — the same way Phase 2 named the four document
+        // types that derive no standards. A forgotten regime is a red test.
+        attribute appliesToRegime : RegulatoryRegimeKind[0..*];
+    }
+
+    item def StandardClause :> MemoArtifactItem {
+        doc /* One normative clause of a RegulatoryStandard, at the depth at
+             * which the standard makes a distinct requirement a MEMO document
+             * actually claims. `title` is a MEMO-authored scope phrase — a
+             * representative synonym for what the clause governs ("§17" →
+             * "electromagnetic compatibility") — never the standard's own
+             * normative wording, which is copyrighted. The scope phrase is a
+             * label: queries traverse ConformsTo to the clause instance, they
+             * never match on its text.
+             *
+             * Clause containment uses the existing Composes relation
+             * (standard as parent, clause as child; clause as parent,
+             * sub-clause as child). There is no clause-specific composition
+             * type, because whole/part decomposition is already one relation
+             * in MEMO. */
+        attribute clauseNumber : String;
+        attribute title : String[0..1];
+        attribute normativeStrength : String[0..1];
+    }
+
+    // =========================================================================
+    // Relationships
+    // =========================================================================
+
+    connection def ConformsTo :> MemoRelationship {
+        doc /* Any model element claims conformance to a standard clause.
+             * This is the edge the standards traceability matrix and the
+             * clause coverage report are computed over. */
+        end conformingElement : MemoPart :>> source;
+        end clause : StandardClause :>> target;
+    }
+    abstract connection conformsToLinks : ConformsTo[*];
+    metadata def <conformsTo> ConformsToMetadata :> SemanticMetadata {
+        :> annotatedElement : SysML::ConnectionDefinition;
+        :> annotatedElement : SysML::ConnectionUsage;
+        :>> baseType = conformsToLinks meta SysML::Usage;
+    }
+
+    connection def TracesToDocument :> MemoRelationship {
+        doc /* Where the evidence for a clause claim is written down. The target
+             * is the existing controlled-artifact type — MEMO does not model a
+             * separate Document/DocumentSection family, because
+             * ControlledArtifact / ModelOwnedArtifact / MarkdownDocumentSource
+             * already carry version, owner and approval status. Section
+             * granularity rides on the link as a reference string rather than
+             * as a duplicate element type. */
+        attribute sectionReference : String[0..1];
+        end tracedElement : MemoPart :>> source;
+        end artifact : ControlledArtifact :>> target;
+    }
+    abstract connection tracesToDocumentLinks : TracesToDocument[*];
+    metadata def <tracesToDocument> TracesToDocumentMetadata :> SemanticMetadata {
+        :> annotatedElement : SysML::ConnectionDefinition;
+        :> annotatedElement : SysML::ConnectionUsage;
+        :>> baseType = tracesToDocumentLinks meta SysML::Usage;
+    }
+}

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-input.md

@@ -33,7 +33,7 @@ empty: "No system requirements defined."
 ### 2.2 Design Inputs from User Needs
 
 ```memo-query
-kind: [DesignInput, Need]
+kind: [Requirement, Need]
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-output.md

@@ -23,8 +23,8 @@ Defines design outputs for **{{project.product}}** per 21 CFR 820.30(d). Design
 ### 2.1 Hardware Design Outputs
 
 ```memo-query
-kind: [Component, Subsystem, DesignOutput]
-where: layer == "physical"
+kind: [HardwareComponent, HardwareAssembly, SoftwareComponent, SoftwareSystem]
+where: layer == "implementation"
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -34,8 +34,8 @@ empty: "No hardware design outputs defined."
 ### 2.2 Software Design Outputs
 
 ```memo-query
-kind: [SoftwareItem, SoftwareUnit, DesignOutput]
-where: layer == "software"
+kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]
+where: layer == "implementation"
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -45,7 +45,7 @@ empty: "No software design outputs defined."
 ### 2.3 All Design Outputs
 
 ```memo-query
-kind: DesignOutput
+kind: [HardwareComponent, HardwareAssembly, SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-review.md

@@ -41,7 +41,7 @@ _[TODO: Track all open action items from design reviews]_
 Snapshot of the design state at the time of review, computed from the model:
 
 ```memo-query
-kind: [Requirement, Requirement, DesignInput, DesignOutput]
+kind: [Requirement, HardwareComponent, HardwareAssembly, SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: count
 label: Total design elements at last review
 ```

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-validation.md

@@ -29,7 +29,7 @@ _[TODO: Reference V&V Plan]_
 Describe clinical or bench validation activities demonstrating conformity with user needs under actual or simulated use conditions.
 
 ```memo-query
-kind: ValidationActivity
+kind: ValidationCase
 display: table
 columns: name, layer, doc
 sort: name
@@ -43,7 +43,7 @@ empty: "No validation activities defined."
 Coverage of user needs by validation activities, computed live from the model:
 
 ```memo-query
-kind: [Need, Requirement]
+kind: [Requirement, Need]
 display: table
 columns: name, layer, doc
 empty: "No user needs defined."

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-verification.md

@@ -21,7 +21,7 @@ Documents design verification that design outputs meet design inputs for **{{pro
 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
+kind: VerificationCase
 display: table
 columns: name, layer, doc
 sort: name
@@ -35,7 +35,7 @@ empty: "No verification activities defined."
 Test executions and their outcomes are summarized below from the model:
 
 ```memo-query
-kind: TestCase
+kind: VerificationCase
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/dhf-index.md

@@ -79,7 +79,7 @@ Key characteristics of **{{project.product}}**, drawn from the model:
 Summary statistics of the system model at the time this document was generated:
 
 ```memo-query
-kind: [Requirement, Requirement]
+kind: Requirement
 display: count
 label: Total requirements
 ```
@@ -91,7 +91,7 @@ label: Total hazards
 ```
 
 ```memo-query
-kind: [TestCase, VerificationActivity]
+kind: VerificationCase
 display: count
 label: Total test cases
 ```

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/transfer-plan.md

@@ -36,7 +36,7 @@ Checklist of items required before design transfer to production is complete:
 Production specifications derived from the design outputs:
 
 ```memo-query
-kind: DesignOutput
+kind: [HardwareComponent, HardwareAssembly, SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/user-needs.md

@@ -31,7 +31,7 @@ _[TODO: Describe all intended user groups with their roles, training levels, and
 User needs captured for **{{project.product}}** are listed below from the model. Each user need should trace forward to at least one design input:
 
 ```memo-query
-kind: [Need, Requirement]
+kind: [Requirement, Need]
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-plan.md

@@ -33,7 +33,7 @@ This plan covers:
 ### 3.1 Requirements to Verify
 
 ```memo-query
-kind: [Requirement, Requirement]
+kind: Requirement
 display: table
 columns: name, layer, doc
 sort: name
@@ -43,7 +43,7 @@ empty: "No requirements defined."
 ### 3.2 Verification Test Cases
 
 ```memo-query
-kind: [TestCase, VerificationActivity]
+kind: VerificationCase
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -57,7 +57,7 @@ empty: "No verification test cases defined."
 Validation activities demonstrating that **{{project.product}}** meets user needs and intended uses:
 
 ```memo-query
-kind: ValidationActivity
+kind: ValidationCase
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-report.md

@@ -23,13 +23,13 @@ This V&V Report documents the results of all verification and validation activit
 Summary metrics computed live from the model:
 
 ```memo-query
-kind: TestCase
+kind: VerificationCase
 display: count
 label: Total test cases
 ```
 
 ```memo-query
-kind: [VerificationActivity, ValidationActivity]
+kind: [VerificationCase, ValidationCase]
 display: count
 label: V&V activities
 ```
@@ -41,7 +41,7 @@ label: V&V activities
 ### 3.1 Test Results by Requirement
 
 ```memo-query
-kind: [TestCase, VerificationActivity]
+kind: VerificationCase
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -55,7 +55,7 @@ empty: "No verification activities defined."
 Results of the validation activities are summarized below:
 
 ```memo-query
-kind: ValidationActivity
+kind: ValidationCase
 display: table
 columns: name, layer, doc
 sort: name