@memoarchitect/tools 0.4.4

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Files changed (588) hide show
  1. package/LICENSE +21 -0
  2. package/README.md +171 -0
  3. package/package.json +86 -0
  4. package/packages/tools/lib/__tests__/archetype-parsing.test.d.ts +2 -0
  5. package/packages/tools/lib/__tests__/archetype-parsing.test.d.ts.map +1 -0
  6. package/packages/tools/lib/__tests__/archetype-parsing.test.js +42 -0
  7. package/packages/tools/lib/__tests__/archetype-parsing.test.js.map +1 -0
  8. package/packages/tools/lib/__tests__/architecture-discovery.test.d.ts +2 -0
  9. package/packages/tools/lib/__tests__/architecture-discovery.test.d.ts.map +1 -0
  10. package/packages/tools/lib/__tests__/architecture-discovery.test.js +82 -0
  11. package/packages/tools/lib/__tests__/architecture-discovery.test.js.map +1 -0
  12. package/packages/tools/lib/__tests__/behavior.test.d.ts +2 -0
  13. package/packages/tools/lib/__tests__/behavior.test.d.ts.map +1 -0
  14. package/packages/tools/lib/__tests__/behavior.test.js +766 -0
  15. package/packages/tools/lib/__tests__/behavior.test.js.map +1 -0
  16. package/packages/tools/lib/__tests__/builder.test.d.ts +2 -0
  17. package/packages/tools/lib/__tests__/builder.test.d.ts.map +1 -0
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  19. package/packages/tools/lib/__tests__/builder.test.js.map +1 -0
  20. package/packages/tools/lib/__tests__/config-loader.test.d.ts +2 -0
  21. package/packages/tools/lib/__tests__/config-loader.test.d.ts.map +1 -0
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  23. package/packages/tools/lib/__tests__/config-loader.test.js.map +1 -0
  24. package/packages/tools/lib/__tests__/conformance.test.d.ts +2 -0
  25. package/packages/tools/lib/__tests__/conformance.test.d.ts.map +1 -0
  26. package/packages/tools/lib/__tests__/conformance.test.js +467 -0
  27. package/packages/tools/lib/__tests__/conformance.test.js.map +1 -0
  28. package/packages/tools/lib/__tests__/constraint-eval.test.d.ts +2 -0
  29. package/packages/tools/lib/__tests__/constraint-eval.test.d.ts.map +1 -0
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  32. package/packages/tools/lib/__tests__/constraint-grammar.test.d.ts +2 -0
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  40. package/packages/tools/lib/__tests__/csv-io.test.d.ts +2 -0
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  42. package/packages/tools/lib/__tests__/csv-io.test.js +317 -0
  43. package/packages/tools/lib/__tests__/csv-io.test.js.map +1 -0
  44. package/packages/tools/lib/__tests__/dhf-doc-store.test.d.ts +2 -0
  45. package/packages/tools/lib/__tests__/dhf-doc-store.test.d.ts.map +1 -0
  46. package/packages/tools/lib/__tests__/dhf-doc-store.test.js +94 -0
  47. package/packages/tools/lib/__tests__/dhf-doc-store.test.js.map +1 -0
  48. package/packages/tools/lib/__tests__/dhf-template-resolver.test.d.ts +2 -0
  49. package/packages/tools/lib/__tests__/dhf-template-resolver.test.d.ts.map +1 -0
  50. package/packages/tools/lib/__tests__/dhf-template-resolver.test.js +39 -0
  51. package/packages/tools/lib/__tests__/dhf-template-resolver.test.js.map +1 -0
  52. package/packages/tools/lib/__tests__/dhf.test.d.ts +2 -0
  53. package/packages/tools/lib/__tests__/dhf.test.d.ts.map +1 -0
  54. package/packages/tools/lib/__tests__/dhf.test.js +393 -0
  55. package/packages/tools/lib/__tests__/dhf.test.js.map +1 -0
  56. package/packages/tools/lib/__tests__/dimension-filter.test.d.ts +2 -0
  57. package/packages/tools/lib/__tests__/dimension-filter.test.d.ts.map +1 -0
  58. package/packages/tools/lib/__tests__/dimension-filter.test.js +85 -0
  59. package/packages/tools/lib/__tests__/dimension-filter.test.js.map +1 -0
  60. package/packages/tools/lib/__tests__/dsm.test.d.ts +2 -0
  61. package/packages/tools/lib/__tests__/dsm.test.d.ts.map +1 -0
  62. package/packages/tools/lib/__tests__/dsm.test.js +112 -0
  63. package/packages/tools/lib/__tests__/dsm.test.js.map +1 -0
  64. package/packages/tools/lib/__tests__/e2e-workflow.test.d.ts +2 -0
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  68. package/packages/tools/lib/__tests__/file-watcher.test.d.ts +2 -0
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  80. package/packages/tools/lib/__tests__/kind-registry.test.d.ts +2 -0
  81. package/packages/tools/lib/__tests__/kind-registry.test.d.ts.map +1 -0
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  83. package/packages/tools/lib/__tests__/kind-registry.test.js.map +1 -0
  84. package/packages/tools/lib/__tests__/llm.test.d.ts +2 -0
  85. package/packages/tools/lib/__tests__/llm.test.d.ts.map +1 -0
  86. package/packages/tools/lib/__tests__/llm.test.js +275 -0
  87. package/packages/tools/lib/__tests__/llm.test.js.map +1 -0
  88. package/packages/tools/lib/__tests__/manifest-resolver.test.d.ts +2 -0
  89. package/packages/tools/lib/__tests__/manifest-resolver.test.d.ts.map +1 -0
  90. package/packages/tools/lib/__tests__/manifest-resolver.test.js +97 -0
  91. package/packages/tools/lib/__tests__/manifest-resolver.test.js.map +1 -0
  92. package/packages/tools/lib/__tests__/markdown-to-ir.test.d.ts +2 -0
  93. package/packages/tools/lib/__tests__/markdown-to-ir.test.d.ts.map +1 -0
  94. package/packages/tools/lib/__tests__/markdown-to-ir.test.js +74 -0
  95. package/packages/tools/lib/__tests__/markdown-to-ir.test.js.map +1 -0
  96. package/packages/tools/lib/__tests__/methodology-scope.test.d.ts +2 -0
  97. package/packages/tools/lib/__tests__/methodology-scope.test.d.ts.map +1 -0
  98. package/packages/tools/lib/__tests__/methodology-scope.test.js +59 -0
  99. package/packages/tools/lib/__tests__/methodology-scope.test.js.map +1 -0
  100. package/packages/tools/lib/__tests__/parser.test.d.ts +2 -0
  101. package/packages/tools/lib/__tests__/parser.test.d.ts.map +1 -0
  102. package/packages/tools/lib/__tests__/parser.test.js +938 -0
  103. package/packages/tools/lib/__tests__/parser.test.js.map +1 -0
  104. package/packages/tools/lib/__tests__/plugin.test.d.ts +2 -0
  105. package/packages/tools/lib/__tests__/plugin.test.d.ts.map +1 -0
  106. package/packages/tools/lib/__tests__/plugin.test.js +308 -0
  107. package/packages/tools/lib/__tests__/plugin.test.js.map +1 -0
  108. package/packages/tools/lib/__tests__/relationship-registry.test.d.ts +2 -0
  109. package/packages/tools/lib/__tests__/relationship-registry.test.d.ts.map +1 -0
  110. package/packages/tools/lib/__tests__/relationship-registry.test.js +96 -0
  111. package/packages/tools/lib/__tests__/relationship-registry.test.js.map +1 -0
  112. package/packages/tools/lib/__tests__/rule-registry.test.d.ts +2 -0
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  115. package/packages/tools/lib/__tests__/rule-registry.test.js.map +1 -0
  116. package/packages/tools/lib/__tests__/toolchain.test.d.ts +2 -0
  117. package/packages/tools/lib/__tests__/toolchain.test.d.ts.map +1 -0
  118. package/packages/tools/lib/__tests__/toolchain.test.js +94 -0
  119. package/packages/tools/lib/__tests__/toolchain.test.js.map +1 -0
  120. package/packages/tools/lib/__tests__/view-deriver-samples.test.d.ts +2 -0
  121. package/packages/tools/lib/__tests__/view-deriver-samples.test.d.ts.map +1 -0
  122. package/packages/tools/lib/__tests__/view-deriver-samples.test.js +39 -0
  123. package/packages/tools/lib/__tests__/view-deriver-samples.test.js.map +1 -0
  124. package/packages/tools/lib/__tests__/view-kinds.test.d.ts +2 -0
  125. package/packages/tools/lib/__tests__/view-kinds.test.d.ts.map +1 -0
  126. package/packages/tools/lib/__tests__/view-kinds.test.js +263 -0
  127. package/packages/tools/lib/__tests__/view-kinds.test.js.map +1 -0
  128. package/packages/tools/lib/__tests__/view-layout-store.test.d.ts +2 -0
  129. package/packages/tools/lib/__tests__/view-layout-store.test.d.ts.map +1 -0
  130. package/packages/tools/lib/__tests__/view-layout-store.test.js +61 -0
  131. package/packages/tools/lib/__tests__/view-layout-store.test.js.map +1 -0
  132. package/packages/tools/lib/analysis/dsm.d.ts +47 -0
  133. package/packages/tools/lib/analysis/dsm.d.ts.map +1 -0
  134. package/packages/tools/lib/analysis/dsm.js +172 -0
  135. package/packages/tools/lib/analysis/dsm.js.map +1 -0
  136. package/packages/tools/lib/analysis/impact.d.ts +35 -0
  137. package/packages/tools/lib/analysis/impact.d.ts.map +1 -0
  138. package/packages/tools/lib/analysis/impact.js +97 -0
  139. package/packages/tools/lib/analysis/impact.js.map +1 -0
  140. package/packages/tools/lib/bin/memo.d.ts +3 -0
  141. package/packages/tools/lib/bin/memo.d.ts.map +1 -0
  142. package/packages/tools/lib/bin/memo.js +461 -0
  143. package/packages/tools/lib/bin/memo.js.map +1 -0
  144. package/packages/tools/lib/browser/index.d.ts +13 -0
  145. package/packages/tools/lib/browser/index.d.ts.map +1 -0
  146. package/packages/tools/lib/browser/index.js +11 -0
  147. package/packages/tools/lib/browser/index.js.map +1 -0
  148. package/packages/tools/lib/commands/archetype-loader.d.ts +15 -0
  149. package/packages/tools/lib/commands/archetype-loader.d.ts.map +1 -0
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  168. package/packages/tools/lib/commands/dhf-draft.d.ts +8 -0
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@@ -0,0 +1,170 @@
1
+ /** Inline text with optional formatting */
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+ export interface DhfText {
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+ type: 'text';
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+ value: string;
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+ bold?: boolean;
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+ italic?: boolean;
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+ code?: boolean;
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+ /** For redline: 'added' | 'removed' | undefined */
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+ change?: 'added' | 'removed';
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+ }
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+ /** A cross-reference to a model element */
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+ export interface DhfXref {
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+ type: 'xref';
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+ elementId: string;
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+ label: string;
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+ kind?: string;
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+ }
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+ /** An inline badge (status indicator) */
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+ export interface DhfInlineBadge {
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+ type: 'badge';
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+ label: string;
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+ variant: 'success' | 'warning' | 'error' | 'info' | 'neutral';
23
+ }
24
+ /** Inline content */
25
+ export type DhfInline = DhfText | DhfXref | DhfInlineBadge;
26
+ /** A table cell */
27
+ export interface DhfCell {
28
+ content: DhfInline[];
29
+ header?: boolean;
30
+ colSpan?: number;
31
+ rowSpan?: number;
32
+ /** For redline rows */
33
+ change?: 'added' | 'removed';
34
+ }
35
+ /** A table row */
36
+ export interface DhfRow {
37
+ cells: DhfCell[];
38
+ change?: 'added' | 'removed';
39
+ }
40
+ /** A paragraph block */
41
+ export interface DhfParagraph {
42
+ type: 'paragraph';
43
+ content: DhfInline[];
44
+ change?: 'added' | 'removed';
45
+ }
46
+ /** A heading block */
47
+ export interface DhfHeading {
48
+ type: 'heading';
49
+ level: 1 | 2 | 3 | 4;
50
+ text: string;
51
+ id?: string;
52
+ }
53
+ /** A table block */
54
+ export interface DhfTable {
55
+ type: 'table';
56
+ headers: DhfCell[];
57
+ rows: DhfRow[];
58
+ caption?: string;
59
+ }
60
+ /** A list block */
61
+ export interface DhfList {
62
+ type: 'list';
63
+ ordered: boolean;
64
+ items: DhfInline[][];
65
+ }
66
+ /** A status badge (for gap/coverage indicators) */
67
+ export interface DhfBadge {
68
+ type: 'badge';
69
+ label: string;
70
+ variant: 'success' | 'warning' | 'error' | 'info' | 'neutral';
71
+ }
72
+ /** A metric card (for summary dashboards) */
73
+ export interface DhfMetric {
74
+ type: 'metric';
75
+ label: string;
76
+ value: string | number;
77
+ unit?: string;
78
+ variant?: 'success' | 'warning' | 'error' | 'neutral';
79
+ }
80
+ /** A metric group */
81
+ export interface DhfMetricGroup {
82
+ type: 'metric-group';
83
+ metrics: DhfMetric[];
84
+ }
85
+ /** A progress bar */
86
+ export interface DhfProgress {
87
+ type: 'progress';
88
+ label: string;
89
+ value: number;
90
+ max: number;
91
+ color?: string;
92
+ }
93
+ /** A horizontal rule / section break */
94
+ export interface DhfDivider {
95
+ type: 'divider';
96
+ }
97
+ /** All block-level IR nodes */
98
+ export type DhfBlock = DhfParagraph | DhfHeading | DhfTable | DhfList | DhfBadge | DhfMetric | DhfMetricGroup | DhfProgress | DhfDivider;
99
+ /** A section in a DHF document */
100
+ export interface DhfDocumentSection {
101
+ id: string;
102
+ title: string;
103
+ blocks: DhfBlock[];
104
+ /** Number of model elements referenced in this section */
105
+ elementCount?: number;
106
+ /** Number of gaps (missing traces/violations) in this section */
107
+ gapCount?: number;
108
+ /** Section status derived from gap analysis */
109
+ status?: 'complete' | 'partial' | 'empty';
110
+ }
111
+ /** Frontmatter metadata for a DHF document */
112
+ export interface DhfFrontmatter {
113
+ /** Document type ID (from registry) */
114
+ documentId: string;
115
+ /** Document title */
116
+ title: string;
117
+ /** Document version */
118
+ version?: string;
119
+ /** Applicable standards */
120
+ standards?: string[];
121
+ /** Organization name */
122
+ organization?: string;
123
+ /** Project name */
124
+ project?: string;
125
+ /** Document phase */
126
+ phase?: string;
127
+ /** Author(s) */
128
+ authors?: string[];
129
+ /** Approvers */
130
+ approvers?: {
131
+ name: string;
132
+ role: string;
133
+ date?: string;
134
+ }[];
135
+ /** Generation timestamp */
136
+ generatedAt: string;
137
+ /** Custom metadata */
138
+ custom?: Record<string, string>;
139
+ }
140
+ /** A complete DHF document in IR form */
141
+ export interface DhfDocument {
142
+ frontmatter: DhfFrontmatter;
143
+ sections: DhfDocumentSection[];
144
+ /** Overall document status */
145
+ status: 'complete' | 'partial' | 'empty';
146
+ /** Total model elements referenced */
147
+ totalElements: number;
148
+ /** Total gaps found */
149
+ totalGaps: number;
150
+ }
151
+ export declare function text(value: string, opts?: {
152
+ bold?: boolean;
153
+ italic?: boolean;
154
+ code?: boolean;
155
+ change?: 'added' | 'removed';
156
+ }): DhfText;
157
+ export declare function xref(elementId: string, label: string, kind?: string): DhfXref;
158
+ export declare function heading(level: 1 | 2 | 3 | 4, title: string, id?: string): DhfHeading;
159
+ export declare function paragraph(...content: DhfInline[]): DhfParagraph;
160
+ export declare function table(headers: string[], rows: DhfInline[][][], caption?: string): DhfTable;
161
+ export declare function list(items: DhfInline[][], ordered?: boolean): DhfList;
162
+ export declare function badge(label: string, variant: DhfBadge['variant']): DhfInlineBadge;
163
+ export declare function metric(label: string, value: string | number, opts?: {
164
+ unit?: string;
165
+ variant?: DhfMetric['variant'];
166
+ }): DhfMetric;
167
+ export declare function metricGroup(...metrics: DhfMetric[]): DhfMetricGroup;
168
+ export declare function progress(label: string, value: number, max: number, color?: string): DhfProgress;
169
+ export declare function divider(): DhfDivider;
170
+ //# sourceMappingURL=document-ir.d.ts.map
@@ -0,0 +1 @@
1
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@@ -0,0 +1,47 @@
1
+ // ─── DHF Document IR (Intermediate Representation) ──────────────────────────
2
+ //
3
+ // Format-agnostic AST for DHF documents. Templates compile to this IR,
4
+ // then export plugins render it to HTML, DOCX, PDF, or Markdown.
5
+ // ─────────────────────────────────────────────────────────────────────────────
6
+ // ─── IR Builder Helpers ──────────────────────────────────────────────────────
7
+ export function text(value, opts) {
8
+ return { type: 'text', value, ...opts };
9
+ }
10
+ export function xref(elementId, label, kind) {
11
+ return { type: 'xref', elementId, label, kind };
12
+ }
13
+ export function heading(level, title, id) {
14
+ return { type: 'heading', level, text: title, id };
15
+ }
16
+ export function paragraph(...content) {
17
+ return { type: 'paragraph', content };
18
+ }
19
+ export function table(headers, rows, caption) {
20
+ return {
21
+ type: 'table',
22
+ headers: headers.map(h => ({ content: [text(h)], header: true })),
23
+ rows: rows.map(cells => ({
24
+ cells: cells.map(content => ({ content })),
25
+ })),
26
+ caption,
27
+ };
28
+ }
29
+ export function list(items, ordered = false) {
30
+ return { type: 'list', ordered, items };
31
+ }
32
+ export function badge(label, variant) {
33
+ return { type: 'badge', label, variant };
34
+ }
35
+ export function metric(label, value, opts) {
36
+ return { type: 'metric', label, value, ...opts };
37
+ }
38
+ export function metricGroup(...metrics) {
39
+ return { type: 'metric-group', metrics };
40
+ }
41
+ export function progress(label, value, max, color) {
42
+ return { type: 'progress', label, value, max, color };
43
+ }
44
+ export function divider() {
45
+ return { type: 'divider' };
46
+ }
47
+ //# sourceMappingURL=document-ir.js.map
@@ -0,0 +1 @@
1
+ {"version":3,"file":"document-ir.js","sourceRoot":"","sources":["../../src/dhf/document-ir.ts"],"names":[],"mappings":"AAAA,+EAA+E;AAC/E,EAAE;AACF,uEAAuE;AACvE,iEAAiE;AACjE,gFAAgF;AAgLhF,gFAAgF;AAEhF,MAAM,UAAU,IAAI,CAAC,KAAa,EAAE,IAAyF;IACzH,OAAO,EAAE,IAAI,EAAE,MAAM,EAAE,KAAK,EAAE,GAAG,IAAI,EAAE,CAAC;AAC5C,CAAC;AAED,MAAM,UAAU,IAAI,CAAC,SAAiB,EAAE,KAAa,EAAE,IAAa;IAChE,OAAO,EAAE,IAAI,EAAE,MAAM,EAAE,SAAS,EAAE,KAAK,EAAE,IAAI,EAAE,CAAC;AACpD,CAAC;AAED,MAAM,UAAU,OAAO,CAAC,KAAoB,EAAE,KAAa,EAAE,EAAW;IACpE,OAAO,EAAE,IAAI,EAAE,SAAS,EAAE,KAAK,EAAE,IAAI,EAAE,KAAK,EAAE,EAAE,EAAE,CAAC;AACvD,CAAC;AAED,MAAM,UAAU,SAAS,CAAC,GAAG,OAAoB;IAC7C,OAAO,EAAE,IAAI,EAAE,WAAW,EAAE,OAAO,EAAE,CAAC;AAC1C,CAAC;AAED,MAAM,UAAU,KAAK,CAAC,OAAiB,EAAE,IAAqB,EAAE,OAAgB;IAC5E,OAAO;QACH,IAAI,EAAE,OAAO;QACb,OAAO,EAAE,OAAO,CAAC,GAAG,CAAC,CAAC,CAAC,EAAE,CAAC,CAAC,EAAE,OAAO,EAAE,CAAC,IAAI,CAAC,CAAC,CAAC,CAAC,EAAE,MAAM,EAAE,IAAI,EAAE,CAAC,CAAC;QACjE,IAAI,EAAE,IAAI,CAAC,GAAG,CAAC,KAAK,CAAC,EAAE,CAAC,CAAC;YACrB,KAAK,EAAE,KAAK,CAAC,GAAG,CAAC,OAAO,CAAC,EAAE,CAAC,CAAC,EAAE,OAAO,EAAE,CAAC,CAAC;SAC7C,CAAC,CAAC;QACH,OAAO;KACV,CAAC;AACN,CAAC;AAED,MAAM,UAAU,IAAI,CAAC,KAAoB,EAAE,OAAO,GAAG,KAAK;IACtD,OAAO,EAAE,IAAI,EAAE,MAAM,EAAE,OAAO,EAAE,KAAK,EAAE,CAAC;AAC5C,CAAC;AAED,MAAM,UAAU,KAAK,CAAC,KAAa,EAAE,OAA4B;IAC7D,OAAO,EAAE,IAAI,EAAE,OAAO,EAAE,KAAK,EAAE,OAAO,EAAE,CAAC;AAC7C,CAAC;AAED,MAAM,UAAU,MAAM,CAAC,KAAa,EAAE,KAAsB,EAAE,IAAwD;IAClH,OAAO,EAAE,IAAI,EAAE,QAAQ,EAAE,KAAK,EAAE,KAAK,EAAE,GAAG,IAAI,EAAE,CAAC;AACrD,CAAC;AAED,MAAM,UAAU,WAAW,CAAC,GAAG,OAAoB;IAC/C,OAAO,EAAE,IAAI,EAAE,cAAc,EAAE,OAAO,EAAE,CAAC;AAC7C,CAAC;AAED,MAAM,UAAU,QAAQ,CAAC,KAAa,EAAE,KAAa,EAAE,GAAW,EAAE,KAAc;IAC9E,OAAO,EAAE,IAAI,EAAE,UAAU,EAAE,KAAK,EAAE,KAAK,EAAE,GAAG,EAAE,KAAK,EAAE,CAAC;AAC1D,CAAC;AAED,MAAM,UAAU,OAAO;IACnB,OAAO,EAAE,IAAI,EAAE,SAAS,EAAE,CAAC;AAC/B,CAAC"}
@@ -0,0 +1,45 @@
1
+ /** A section within a DHF document template */
2
+ export interface DhfSection {
3
+ id: string;
4
+ title: string;
5
+ /** Handlebars template content or static markdown */
6
+ description?: string;
7
+ /** Whether this section is required for the document to be considered complete */
8
+ required: boolean;
9
+ }
10
+ /** A registered DHF document type */
11
+ export interface DhfDocumentType {
12
+ /** Short identifier, e.g. "rmp", "har", "fmea" */
13
+ id: string;
14
+ /** Full document title */
15
+ title: string;
16
+ /** Regulatory standard references */
17
+ standards: string[];
18
+ /** Architecture layers this document draws from */
19
+ layers: string[];
20
+ /** Element kinds relevant to this document */
21
+ relevantKinds: string[];
22
+ /** Relationship types relevant to this document */
23
+ relevantRelationships: string[];
24
+ /** Default sections */
25
+ sections: DhfSection[];
26
+ /** Document group for CLI aliases */
27
+ group: 'risk' | 'design' | 'verification' | 'compliance' | 'all';
28
+ }
29
+ /** The 18 DHF document types for medical device development */
30
+ export declare const DHF_DOCUMENT_TYPES: DhfDocumentType[];
31
+ /** Get a document type by ID */
32
+ export declare function getDocumentType(id: string): DhfDocumentType | undefined;
33
+ /** Get all document types in a group */
34
+ export declare function getDocumentsByGroup(group: string): DhfDocumentType[];
35
+ /** All document IDs */
36
+ export declare function getAllDocumentIds(): string[];
37
+ /**
38
+ * Resolve a DHF document type through an artifact kind name from the ontology.
39
+ * Falls back to built-in document types when no artifact kind mapping exists.
40
+ *
41
+ * @param artifactKindOrDocId - Artifact kind name (e.g. "RiskManagementPlan") or document ID (e.g. "rmp")
42
+ * @returns The matching DhfDocumentType, or undefined if no match
43
+ */
44
+ export declare function resolveDocumentType(artifactKindOrDocId: string): DhfDocumentType | undefined;
45
+ //# sourceMappingURL=document-registry.d.ts.map
@@ -0,0 +1 @@
1
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+ // ─── DHF Document Registry ───────────────────────────────────────────────────
2
+ //
3
+ // Registry of 18 regulated document types for medical device Design History File.
4
+ // Each document type has a unique ID, title, standard references, and section defs.
5
+ //
6
+ // Terminology note: "DHF" is the FDA's legacy QSR term (21 CFR 820.30(j)). Under
7
+ // QMSR (effective Feb 2026), which incorporates ISO 13485:2016 by reference, the
8
+ // equivalent record is the "design and development file" (ISO 13485 §7.3.10) —
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+ // the regulation text no longer says "DHF". Kept as "DHF" here since that's still
10
+ // the term practitioners and eQMS tooling use; not a functional distinction.
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+ // ─────────────────────────────────────────────────────────────────────────────
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+ /** The 18 DHF document types for medical device development */
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+ export const DHF_DOCUMENT_TYPES = [
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+ // ─── Risk Management ─────────────────────────────────────────────────
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+ {
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+ id: 'rmp',
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+ title: 'Risk Management Plan',
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+ standards: ['ISO 14971:2019 §4.4'],
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+ layers: ['risk'],
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+ relevantKinds: ['Hazard', 'HazardousSituation', 'Harm', 'RiskControl', 'RiskAcceptabilityCriteria'],
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+ relevantRelationships: ['mitigates', 'causedBy', 'leadsTo'],
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+ group: 'risk',
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+ sections: [
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+ { id: 'scope', title: 'Scope', required: true },
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+ { id: 'risk-policy', title: 'Risk Acceptability Policy', required: true },
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+ { id: 'risk-process', title: 'Risk Management Process', required: true },
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+ { id: 'verification-activities', title: 'Verification of Risk Control Measures', required: true },
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+ { id: 'residual-risk', title: 'Overall Residual Risk Evaluation', required: true },
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+ { id: 'review', title: 'Risk Management Review', required: false },
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+ ],
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+ },
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+ {
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+ id: 'har',
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+ title: 'Hazard Analysis Report',
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+ standards: ['ISO 14971:2019 §5', 'ISO 14971:2019 §6'],
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+ layers: ['risk'],
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+ relevantKinds: ['Hazard', 'HazardousSituation', 'Harm', 'RiskControl'],
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+ relevantRelationships: ['mitigates', 'causedBy', 'leadsTo', 'identifiedIn'],
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+ group: 'risk',
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+ sections: [
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+ { id: 'hazard-identification', title: 'Hazard Identification', required: true },
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+ { id: 'risk-estimation', title: 'Risk Estimation', required: true },
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+ { id: 'risk-evaluation', title: 'Risk Evaluation', required: true },
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+ { id: 'risk-controls', title: 'Risk Control Measures', required: true },
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+ { id: 'residual-risk', title: 'Residual Risk Assessment', required: true },
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+ ],
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+ },
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+ {
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+ id: 'fmea',
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+ title: 'Failure Mode and Effects Analysis',
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+ standards: ['IEC 60812:2018'],
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+ layers: ['risk', 'functional', 'physical'],
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+ relevantKinds: ['Hazard', 'RiskControl', 'Function', 'Component', 'Subsystem'],
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+ relevantRelationships: ['mitigates', 'allocatedTo', 'performs'],
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+ group: 'risk',
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+ sections: [
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+ { id: 'scope', title: 'FMEA Scope & Boundaries', required: true },
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+ { id: 'function-analysis', title: 'Function Analysis', required: true },
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+ { id: 'failure-modes', title: 'Failure Mode Identification', required: true },
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+ { id: 'effects-analysis', title: 'Effects Analysis', required: true },
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+ { id: 'risk-priority', title: 'Risk Priority Numbers', required: true },
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+ { id: 'actions', title: 'Recommended Actions', required: false },
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+ ],
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+ },
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+ // ─── Traceability ────────────────────────────────────────────────────
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+ {
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+ id: 'rtm',
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+ title: 'Requirements Traceability Matrix',
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+ standards: ['IEC 62304:2006 §5.1.1', 'ISO 13485:2016 §7.3.3'],
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+ layers: ['requirements', 'functional', 'verification'],
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+ relevantKinds: ['Requirement', 'Requirement', 'DesignInput', 'DesignOutput', 'TestCase', 'VerificationActivity'],
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+ relevantRelationships: ['traceTo', 'satisfies', 'verifies', 'derivedFrom'],
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+ group: 'design',
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+ sections: [
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+ { id: 'requirements-list', title: 'Requirements Inventory', required: true },
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+ { id: 'design-trace', title: 'Requirements → Design Traceability', required: true },
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+ { id: 'verification-trace', title: 'Requirements → Verification Traceability', required: true },
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+ { id: 'coverage-summary', title: 'Coverage Summary', required: true },
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+ { id: 'gaps', title: 'Traceability Gaps', required: false },
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+ ],
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+ },
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+ // ─── Architecture ────────────────────────────────────────────────────
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+ {
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+ id: 'sad',
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+ title: 'System Architecture Description',
86
+ standards: ['ISO/IEC/IEEE 42010:2022', 'IEC 62304:2006 §5.3'],
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+ layers: ['functional', 'logical', 'physical', 'software', 'interfaces'],
88
+ relevantKinds: ['Function', 'Component', 'Subsystem', 'Interface', 'Port', 'SoftwareItem', 'SOUPComponent'],
89
+ relevantRelationships: ['composedOf', 'allocatedTo', 'connectedTo', 'dependsOn', 'implements'],
90
+ group: 'design',
91
+ sections: [
92
+ { id: 'system-overview', title: 'System Overview', required: true },
93
+ { id: 'functional-arch', title: 'Functional Architecture', required: true },
94
+ { id: 'physical-arch', title: 'Physical Architecture', required: true },
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+ { id: 'software-arch', title: 'Software Architecture', required: true },
96
+ { id: 'interface-spec', title: 'Interface Specification', required: true },
97
+ { id: 'allocation', title: 'Function-to-Component Allocation', required: false },
98
+ ],
99
+ },
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+ {
101
+ id: 'sds',
102
+ title: 'Software Design Specification',
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+ standards: ['IEC 62304:2006 §5.4'],
104
+ layers: ['software'],
105
+ relevantKinds: ['SoftwareItem', 'SoftwareUnit', 'SoftwareSystem', 'SOUPComponent', 'Interface'],
106
+ relevantRelationships: ['composedOf', 'dependsOn', 'implements', 'connectedTo'],
107
+ group: 'design',
108
+ sections: [
109
+ { id: 'software-items', title: 'Software Items', required: true },
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+ { id: 'interfaces', title: 'Software Interfaces', required: true },
111
+ { id: 'soup', title: 'SOUP Components', required: true },
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+ { id: 'decomposition', title: 'Software Decomposition', required: true },
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+ ],
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+ },
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+ {
116
+ id: 'soup',
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+ title: 'SOUP List (Software of Unknown Provenance)',
118
+ standards: ['IEC 62304:2006 §8.1.2'],
119
+ layers: ['software'],
120
+ relevantKinds: ['SOUPComponent'],
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+ relevantRelationships: ['dependsOn', 'usedBy'],
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+ group: 'design',
123
+ sections: [
124
+ { id: 'soup-inventory', title: 'SOUP Component Inventory', required: true },
125
+ { id: 'risk-assessment', title: 'SOUP Risk Assessment', required: true },
126
+ { id: 'version-management', title: 'Version Management', required: true },
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+ ],
128
+ },
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+ // ─── Design Control ──────────────────────────────────────────────────
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+ {
131
+ id: 'dip',
132
+ title: 'Design Input Plan',
133
+ standards: ['ISO 13485:2016 §7.3.3'],
134
+ layers: ['requirements', 'business'],
135
+ relevantKinds: ['DesignInput', 'Requirement', 'StakeholderNeed', 'UseCase'],
136
+ relevantRelationships: ['traceTo', 'derivedFrom', 'satisfies'],
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+ group: 'design',
138
+ sections: [
139
+ { id: 'stakeholder-needs', title: 'Stakeholder Needs', required: true },
140
+ { id: 'design-inputs', title: 'Design Inputs', required: true },
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+ { id: 'trace-to-needs', title: 'Input-to-Need Traceability', required: true },
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+ ],
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+ },
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+ {
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+ id: 'dop',
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+ title: 'Design Output Plan',
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+ standards: ['ISO 13485:2016 §7.3.4'],
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+ layers: ['functional', 'physical', 'software'],
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+ relevantKinds: ['DesignOutput', 'Component', 'SoftwareItem', 'Function'],
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+ relevantRelationships: ['satisfies', 'implements', 'allocatedTo'],
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+ group: 'design',
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+ sections: [
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+ { id: 'design-outputs', title: 'Design Outputs', required: true },
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+ { id: 'output-to-input', title: 'Output-to-Input Traceability', required: true },
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+ ],
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+ },
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+ // ─── Verification & Validation ───────────────────────────────────────
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+ {
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+ id: 'vvp',
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+ title: 'Verification & Validation Plan',
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+ standards: ['ISO 13485:2016 §7.3.6', 'IEC 62304:2006 §5.7'],
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+ layers: ['verification'],
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+ relevantKinds: ['TestCase', 'VerificationActivity', 'ValidationActivity', 'TestProtocol'],
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+ relevantRelationships: ['verifies', 'validates', 'traceTo'],
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+ group: 'verification',
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+ sections: [
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+ { id: 'verification-strategy', title: 'Verification Strategy', required: true },
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+ { id: 'test-cases', title: 'Test Cases', required: true },
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+ { id: 'acceptance-criteria', title: 'Acceptance Criteria', required: true },
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+ { id: 'validation-plan', title: 'Validation Plan', required: false },
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+ ],
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+ },
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+ {
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+ id: 'vvr',
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+ title: 'Verification & Validation Report',
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+ standards: ['ISO 13485:2016 §7.3.7', 'IEC 62304:2006 §5.8'],
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+ layers: ['verification'],
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+ relevantKinds: ['TestCase', 'VerificationActivity', 'ValidationActivity', 'TestResult'],
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+ relevantRelationships: ['verifies', 'validates', 'traceTo'],
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+ group: 'verification',
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+ sections: [
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+ { id: 'results-summary', title: 'Results Summary', required: true },
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+ { id: 'test-results', title: 'Test Results', required: true },
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+ { id: 'deviations', title: 'Deviations & Non-Conformances', required: false },
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+ { id: 'conclusion', title: 'Conclusion', required: true },
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+ ],
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+ },
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+ // ─── Compliance ──────────────────────────────────────────────────────
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+ {
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+ id: 'sdp',
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+ title: 'Software Development Plan',
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+ standards: ['IEC 62304:2006 §5.1'],
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+ layers: ['software', 'verification'],
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+ relevantKinds: ['SoftwareItem', 'SoftwareUnit', 'SoftwareSystem', 'TestCase'],
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+ relevantRelationships: ['composedOf', 'verifies', 'implements'],
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+ group: 'compliance',
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+ sections: [
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+ { id: 'scope', title: 'Scope & Software Safety Class', required: true },
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+ { id: 'lifecycle', title: 'Software Development Life Cycle', required: true },
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+ { id: 'deliverables', title: 'Deliverables', required: true },
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+ { id: 'tools', title: 'Development Tools & Environment', required: false },
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+ ],
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+ },
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+ {
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+ id: 'csr',
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+ title: 'Clinical Safety Report',
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+ standards: ['ISO 14971:2019 §10'],
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+ layers: ['risk', 'verification'],
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+ relevantKinds: ['Hazard', 'RiskControl', 'ClinicalEvidence', 'ValidationActivity'],
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+ relevantRelationships: ['mitigates', 'validates', 'supports'],
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+ group: 'compliance',
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+ sections: [
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+ { id: 'safety-summary', title: 'Safety Summary', required: true },
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+ { id: 'risk-benefit', title: 'Risk-Benefit Analysis', required: true },
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+ { id: 'post-market', title: 'Post-Market Surveillance Plan', required: false },
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+ ],
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+ },
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+ {
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+ id: 'uer',
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+ title: 'Usability Engineering Report',
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+ standards: ['IEC 62366-1:2015'],
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+ layers: ['ui', 'requirements'],
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+ relevantKinds: ['UseCase', 'UserActivity', 'UserInterface', 'UsabilityRequirement'],
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+ relevantRelationships: ['performs', 'interactsWith', 'satisfies'],
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+ group: 'compliance',
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+ sections: [
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+ { id: 'use-specification', title: 'Use Specification', required: true },
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+ { id: 'use-scenarios', title: 'Use Scenarios', required: true },
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+ { id: 'hazard-related-use', title: 'Hazard-Related Use Scenarios', required: true },
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+ { id: 'evaluation', title: 'Usability Evaluation', required: false },
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+ ],
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+ },
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+ {
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+ id: 'cybersecurity',
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+ title: 'Cybersecurity Documentation',
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+ standards: ['IEC 81001-5-1:2021'],
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+ layers: ['software', 'interfaces'],
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+ relevantKinds: ['ThreatModel', 'SecurityControl', 'Interface', 'SOUPComponent'],
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+ relevantRelationships: ['mitigates', 'connectedTo', 'dependsOn'],
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+ group: 'compliance',
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+ sections: [
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+ { id: 'threat-model', title: 'Threat Model', required: true },
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+ { id: 'security-controls', title: 'Security Controls', required: true },
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+ { id: 'vulnerability-assessment', title: 'Vulnerability Assessment', required: false },
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+ ],
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+ },
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+ {
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+ id: 'labeling',
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+ title: 'Labeling Specification',
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+ standards: ['21 CFR 801', 'MDR Annex I §23'],
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+ layers: ['requirements', 'ui'],
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+ relevantKinds: ['LabelingRequirement', 'Requirement'],
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+ relevantRelationships: ['traceTo', 'satisfies'],
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+ group: 'compliance',
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+ sections: [
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+ { id: 'label-content', title: 'Label Content Requirements', required: true },
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+ { id: 'ifu', title: 'Instructions for Use', required: true },
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+ { id: 'udi', title: 'Unique Device Identification', required: false },
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+ ],
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+ },
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+ {
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+ id: 'dhf-index',
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+ title: 'Design History File Index',
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+ standards: ['ISO 13485:2016 §4.2.4', '21 CFR 820.30'],
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+ layers: [],
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+ relevantKinds: [],
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+ relevantRelationships: [],
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+ group: 'all',
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+ sections: [
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+ { id: 'document-list', title: 'Document Inventory', required: true },
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+ { id: 'status-summary', title: 'Status Summary', required: true },
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+ { id: 'completeness', title: 'Completeness Overview', required: true },
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+ { id: 'approvals', title: 'Approval History', required: false },
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+ ],
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+ },
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+ {
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+ id: 'change-log',
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+ title: 'Design Change Log',
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+ standards: ['ISO 13485:2016 §7.3.9'],
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+ layers: [],
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+ relevantKinds: [],
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+ relevantRelationships: [],
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+ group: 'all',
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+ sections: [
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+ { id: 'changes', title: 'Change History', required: true },
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+ { id: 'impact-assessment', title: 'Impact Assessment', required: false },
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+ { id: 'approvals', title: 'Change Approvals', required: false },
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+ ],
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+ },
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+ ];
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+ /** Get a document type by ID */
292
+ export function getDocumentType(id) {
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+ return DHF_DOCUMENT_TYPES.find(d => d.id === id);
294
+ }
295
+ /** Get all document types in a group */
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+ export function getDocumentsByGroup(group) {
297
+ if (group === 'all')
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+ return DHF_DOCUMENT_TYPES;
299
+ return DHF_DOCUMENT_TYPES.filter(d => d.group === group || d.group === 'all');
300
+ }
301
+ /** All document IDs */
302
+ export function getAllDocumentIds() {
303
+ return DHF_DOCUMENT_TYPES.map(d => d.id);
304
+ }
305
+ // ─── Artifact Kind → DHF Document Lookup (Epic E) ──────────────────────────
306
+ const ARTIFACT_KIND_TO_DHF = {
307
+ RiskManagementPlan: 'rmp',
308
+ RequirementsSpecification: 'dip',
309
+ SystemArchitectureDescription: 'sad',
310
+ SoftwareDesignDescription: 'sds',
311
+ HazardAnalysisReport: 'har',
312
+ RequirementsTraceabilityMatrix: 'rtm',
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+ TestProtocol: 'vvp',
314
+ TestReport: 'vvr',
315
+ EvidenceRecord: 'dhf-index',
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+ CybersecurityAssessmentReport: 'cybersecurity',
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+ ThreatModelReport: 'cybersecurity',
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+ UsabilityEngineeringReport: 'uer',
319
+ ClinicalSafetyReport: 'csr',
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+ FailureModeEffectsAnalysisReport: 'fmea',
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+ SoupList: 'soup',
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+ DesignInputPlan: 'dip',
323
+ DesignOutputPlan: 'dop',
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+ SoftwareDevelopmentPlan: 'sdp',
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+ LabelingSpecification: 'labeling',
326
+ DesignHistoryFileIndex: 'dhf-index',
327
+ DesignChangeLog: 'change-log',
328
+ };
329
+ /**
330
+ * Resolve a DHF document type through an artifact kind name from the ontology.
331
+ * Falls back to built-in document types when no artifact kind mapping exists.
332
+ *
333
+ * @param artifactKindOrDocId - Artifact kind name (e.g. "RiskManagementPlan") or document ID (e.g. "rmp")
334
+ * @returns The matching DhfDocumentType, or undefined if no match
335
+ */
336
+ export function resolveDocumentType(artifactKindOrDocId) {
337
+ const dhfId = ARTIFACT_KIND_TO_DHF[artifactKindOrDocId];
338
+ if (dhfId)
339
+ return getDocumentType(dhfId);
340
+ return getDocumentType(artifactKindOrDocId);
341
+ }
342
+ //# sourceMappingURL=document-registry.js.map
@@ -0,0 +1 @@
1
+ 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