@memoarchitect/tools 0.4.4
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- package/LICENSE +21 -0
- package/README.md +171 -0
- package/package.json +86 -0
- package/packages/tools/lib/__tests__/archetype-parsing.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/archetype-parsing.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/archetype-parsing.test.js +42 -0
- package/packages/tools/lib/__tests__/archetype-parsing.test.js.map +1 -0
- package/packages/tools/lib/__tests__/architecture-discovery.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/architecture-discovery.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/architecture-discovery.test.js +82 -0
- package/packages/tools/lib/__tests__/architecture-discovery.test.js.map +1 -0
- package/packages/tools/lib/__tests__/behavior.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/behavior.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/behavior.test.js +766 -0
- package/packages/tools/lib/__tests__/behavior.test.js.map +1 -0
- package/packages/tools/lib/__tests__/builder.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/builder.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/builder.test.js +728 -0
- package/packages/tools/lib/__tests__/builder.test.js.map +1 -0
- package/packages/tools/lib/__tests__/config-loader.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/config-loader.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/config-loader.test.js +196 -0
- package/packages/tools/lib/__tests__/config-loader.test.js.map +1 -0
- package/packages/tools/lib/__tests__/conformance.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/conformance.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/conformance.test.js +467 -0
- package/packages/tools/lib/__tests__/conformance.test.js.map +1 -0
- package/packages/tools/lib/__tests__/constraint-eval.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/constraint-eval.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/constraint-eval.test.js +195 -0
- package/packages/tools/lib/__tests__/constraint-eval.test.js.map +1 -0
- package/packages/tools/lib/__tests__/constraint-grammar.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/constraint-grammar.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/constraint-grammar.test.js +163 -0
- package/packages/tools/lib/__tests__/constraint-grammar.test.js.map +1 -0
- package/packages/tools/lib/__tests__/constraint-loader.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/constraint-loader.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/constraint-loader.test.js +150 -0
- package/packages/tools/lib/__tests__/constraint-loader.test.js.map +1 -0
- package/packages/tools/lib/__tests__/csv-io.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/csv-io.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/csv-io.test.js +317 -0
- package/packages/tools/lib/__tests__/csv-io.test.js.map +1 -0
- package/packages/tools/lib/__tests__/dhf-doc-store.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/dhf-doc-store.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/dhf-doc-store.test.js +94 -0
- package/packages/tools/lib/__tests__/dhf-doc-store.test.js.map +1 -0
- package/packages/tools/lib/__tests__/dhf-template-resolver.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/dhf-template-resolver.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/dhf-template-resolver.test.js +39 -0
- package/packages/tools/lib/__tests__/dhf-template-resolver.test.js.map +1 -0
- package/packages/tools/lib/__tests__/dhf.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/dhf.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/dhf.test.js +393 -0
- package/packages/tools/lib/__tests__/dhf.test.js.map +1 -0
- package/packages/tools/lib/__tests__/dimension-filter.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/dimension-filter.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/dimension-filter.test.js +85 -0
- package/packages/tools/lib/__tests__/dimension-filter.test.js.map +1 -0
- package/packages/tools/lib/__tests__/dsm.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/dsm.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/dsm.test.js +112 -0
- package/packages/tools/lib/__tests__/dsm.test.js.map +1 -0
- package/packages/tools/lib/__tests__/e2e-workflow.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/e2e-workflow.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/e2e-workflow.test.js +707 -0
- package/packages/tools/lib/__tests__/e2e-workflow.test.js.map +1 -0
- package/packages/tools/lib/__tests__/file-watcher.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/file-watcher.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/file-watcher.test.js +31 -0
- package/packages/tools/lib/__tests__/file-watcher.test.js.map +1 -0
- package/packages/tools/lib/__tests__/impact.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/impact.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/impact.test.js +82 -0
- package/packages/tools/lib/__tests__/impact.test.js.map +1 -0
- package/packages/tools/lib/__tests__/importer.test.d.ts +2 -0
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- package/packages/tools/lib/__tests__/importer.test.js.map +1 -0
- package/packages/tools/lib/__tests__/kind-registry.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/kind-registry.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/kind-registry.test.js +132 -0
- package/packages/tools/lib/__tests__/kind-registry.test.js.map +1 -0
- package/packages/tools/lib/__tests__/llm.test.d.ts +2 -0
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- package/packages/tools/lib/__tests__/llm.test.js.map +1 -0
- package/packages/tools/lib/__tests__/manifest-resolver.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/manifest-resolver.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/manifest-resolver.test.js +97 -0
- package/packages/tools/lib/__tests__/manifest-resolver.test.js.map +1 -0
- package/packages/tools/lib/__tests__/markdown-to-ir.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/markdown-to-ir.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/markdown-to-ir.test.js +74 -0
- package/packages/tools/lib/__tests__/markdown-to-ir.test.js.map +1 -0
- package/packages/tools/lib/__tests__/methodology-scope.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/methodology-scope.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/methodology-scope.test.js +59 -0
- package/packages/tools/lib/__tests__/methodology-scope.test.js.map +1 -0
- package/packages/tools/lib/__tests__/parser.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/parser.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/parser.test.js +938 -0
- package/packages/tools/lib/__tests__/parser.test.js.map +1 -0
- package/packages/tools/lib/__tests__/plugin.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/plugin.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/plugin.test.js +308 -0
- package/packages/tools/lib/__tests__/plugin.test.js.map +1 -0
- package/packages/tools/lib/__tests__/relationship-registry.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/relationship-registry.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/relationship-registry.test.js +96 -0
- package/packages/tools/lib/__tests__/relationship-registry.test.js.map +1 -0
- package/packages/tools/lib/__tests__/rule-registry.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/rule-registry.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/rule-registry.test.js +53 -0
- package/packages/tools/lib/__tests__/rule-registry.test.js.map +1 -0
- package/packages/tools/lib/__tests__/toolchain.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/toolchain.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/toolchain.test.js +94 -0
- package/packages/tools/lib/__tests__/toolchain.test.js.map +1 -0
- package/packages/tools/lib/__tests__/view-deriver-samples.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/view-deriver-samples.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/view-deriver-samples.test.js +39 -0
- package/packages/tools/lib/__tests__/view-deriver-samples.test.js.map +1 -0
- package/packages/tools/lib/__tests__/view-kinds.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/view-kinds.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/view-kinds.test.js +263 -0
- package/packages/tools/lib/__tests__/view-kinds.test.js.map +1 -0
- package/packages/tools/lib/__tests__/view-layout-store.test.d.ts +2 -0
- package/packages/tools/lib/__tests__/view-layout-store.test.d.ts.map +1 -0
- package/packages/tools/lib/__tests__/view-layout-store.test.js +61 -0
- package/packages/tools/lib/__tests__/view-layout-store.test.js.map +1 -0
- package/packages/tools/lib/analysis/dsm.d.ts +47 -0
- package/packages/tools/lib/analysis/dsm.d.ts.map +1 -0
- package/packages/tools/lib/analysis/dsm.js +172 -0
- package/packages/tools/lib/analysis/dsm.js.map +1 -0
- package/packages/tools/lib/analysis/impact.d.ts +35 -0
- package/packages/tools/lib/analysis/impact.d.ts.map +1 -0
- package/packages/tools/lib/analysis/impact.js +97 -0
- package/packages/tools/lib/analysis/impact.js.map +1 -0
- package/packages/tools/lib/bin/memo.d.ts +3 -0
- package/packages/tools/lib/bin/memo.d.ts.map +1 -0
- package/packages/tools/lib/bin/memo.js +461 -0
- package/packages/tools/lib/bin/memo.js.map +1 -0
- package/packages/tools/lib/browser/index.d.ts +13 -0
- package/packages/tools/lib/browser/index.d.ts.map +1 -0
- package/packages/tools/lib/browser/index.js +11 -0
- package/packages/tools/lib/browser/index.js.map +1 -0
- package/packages/tools/lib/commands/archetype-loader.d.ts +15 -0
- package/packages/tools/lib/commands/archetype-loader.d.ts.map +1 -0
- package/packages/tools/lib/commands/archetype-loader.js +31 -0
- package/packages/tools/lib/commands/archetype-loader.js.map +1 -0
- package/packages/tools/lib/commands/ask.d.ts +6 -0
- package/packages/tools/lib/commands/ask.d.ts.map +1 -0
- package/packages/tools/lib/commands/ask.js +79 -0
- package/packages/tools/lib/commands/ask.js.map +1 -0
- package/packages/tools/lib/commands/check.d.ts +6 -0
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- package/packages/tools/lib/commands/check.js +214 -0
- package/packages/tools/lib/commands/check.js.map +1 -0
- package/packages/tools/lib/commands/create-package.d.ts +12 -0
- package/packages/tools/lib/commands/create-package.d.ts.map +1 -0
- package/packages/tools/lib/commands/create-package.js +293 -0
- package/packages/tools/lib/commands/create-package.js.map +1 -0
- package/packages/tools/lib/commands/dev.d.ts +6 -0
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- package/packages/tools/lib/commands/dev.js +316 -0
- package/packages/tools/lib/commands/dev.js.map +1 -0
- package/packages/tools/lib/commands/dhf-draft.d.ts +8 -0
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- package/packages/tools/lib/commands/dhf-init.js.map +1 -0
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- package/packages/tools/lib/commands/dhf.d.ts.map +1 -0
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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';
|
|
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|
+
}
|
|
72
|
+
/** A metric card (for summary dashboards) */
|
|
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|
+
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 {
|
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+
id: string;
|
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4
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+
title: string;
|
|
5
|
+
/** Handlebars template content or static markdown */
|
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6
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+
description?: string;
|
|
7
|
+
/** Whether this section is required for the document to be considered complete */
|
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8
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+
required: boolean;
|
|
9
|
+
}
|
|
10
|
+
/** A registered DHF document type */
|
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export interface DhfDocumentType {
|
|
12
|
+
/** Short identifier, e.g. "rmp", "har", "fmea" */
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+
id: string;
|
|
14
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/** Full document title */
|
|
15
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title: string;
|
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16
|
+
/** Regulatory standard references */
|
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17
|
+
standards: string[];
|
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18
|
+
/** Architecture layers this document draws from */
|
|
19
|
+
layers: string[];
|
|
20
|
+
/** Element kinds relevant to this document */
|
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21
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+
relevantKinds: string[];
|
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22
|
+
/** Relationship types relevant to this document */
|
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23
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+
relevantRelationships: string[];
|
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24
|
+
/** Default sections */
|
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25
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+
sections: DhfSection[];
|
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26
|
+
/** Document group for CLI aliases */
|
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27
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+
group: 'risk' | 'design' | 'verification' | 'compliance' | 'all';
|
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+
}
|
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29
|
+
/** The 18 DHF document types for medical device development */
|
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|
+
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.
|
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|
+
*
|
|
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
|
+
{"version":3,"file":"document-registry.d.ts","sourceRoot":"","sources":["../../src/dhf/document-registry.ts"],"names":[],"mappings":"AAYA,+CAA+C;AAC/C,MAAM,WAAW,UAAU;IACvB,EAAE,EAAE,MAAM,CAAC;IACX,KAAK,EAAE,MAAM,CAAC;IACd,qDAAqD;IACrD,WAAW,CAAC,EAAE,MAAM,CAAC;IACrB,kFAAkF;IAClF,QAAQ,EAAE,OAAO,CAAC;CACrB;AAED,qCAAqC;AACrC,MAAM,WAAW,eAAe;IAC5B,kDAAkD;IAClD,EAAE,EAAE,MAAM,CAAC;IACX,0BAA0B;IAC1B,KAAK,EAAE,MAAM,CAAC;IACd,qCAAqC;IACrC,SAAS,EAAE,MAAM,EAAE,CAAC;IACpB,mDAAmD;IACnD,MAAM,EAAE,MAAM,EAAE,CAAC;IACjB,8CAA8C;IAC9C,aAAa,EAAE,MAAM,EAAE,CAAC;IACxB,mDAAmD;IACnD,qBAAqB,EAAE,MAAM,EAAE,CAAC;IAChC,uBAAuB;IACvB,QAAQ,EAAE,UAAU,EAAE,CAAC;IACvB,qCAAqC;IACrC,KAAK,EAAE,MAAM,GAAG,QAAQ,GAAG,cAAc,GAAG,YAAY,GAAG,KAAK,CAAC;CACpE;AAED,+DAA+D;AAC/D,eAAO,MAAM,kBAAkB,EAAE,eAAe,EA0R/C,CAAC;AAEF,gCAAgC;AAChC,wBAAgB,eAAe,CAAC,EAAE,EAAE,MAAM,GAAG,eAAe,GAAG,SAAS,CAEvE;AAED,wCAAwC;AACxC,wBAAgB,mBAAmB,CAAC,KAAK,EAAE,MAAM,GAAG,eAAe,EAAE,CAGpE;AAED,uBAAuB;AACvB,wBAAgB,iBAAiB,IAAI,MAAM,EAAE,CAE5C;AA4BD;;;;;;GAMG;AACH,wBAAgB,mBAAmB,CAAC,mBAAmB,EAAE,MAAM,GAAG,eAAe,GAAG,SAAS,CAI5F"}
|
|
@@ -0,0 +1,342 @@
|
|
|
1
|
+
// ─── 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) —
|
|
9
|
+
// 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.
|
|
11
|
+
// ─────────────────────────────────────────────────────────────────────────────
|
|
12
|
+
/** The 18 DHF document types for medical device development */
|
|
13
|
+
export const DHF_DOCUMENT_TYPES = [
|
|
14
|
+
// ─── Risk Management ─────────────────────────────────────────────────
|
|
15
|
+
{
|
|
16
|
+
id: 'rmp',
|
|
17
|
+
title: 'Risk Management Plan',
|
|
18
|
+
standards: ['ISO 14971:2019 §4.4'],
|
|
19
|
+
layers: ['risk'],
|
|
20
|
+
relevantKinds: ['Hazard', 'HazardousSituation', 'Harm', 'RiskControl', 'RiskAcceptabilityCriteria'],
|
|
21
|
+
relevantRelationships: ['mitigates', 'causedBy', 'leadsTo'],
|
|
22
|
+
group: 'risk',
|
|
23
|
+
sections: [
|
|
24
|
+
{ id: 'scope', title: 'Scope', required: true },
|
|
25
|
+
{ id: 'risk-policy', title: 'Risk Acceptability Policy', required: true },
|
|
26
|
+
{ id: 'risk-process', title: 'Risk Management Process', required: true },
|
|
27
|
+
{ id: 'verification-activities', title: 'Verification of Risk Control Measures', required: true },
|
|
28
|
+
{ id: 'residual-risk', title: 'Overall Residual Risk Evaluation', required: true },
|
|
29
|
+
{ id: 'review', title: 'Risk Management Review', required: false },
|
|
30
|
+
],
|
|
31
|
+
},
|
|
32
|
+
{
|
|
33
|
+
id: 'har',
|
|
34
|
+
title: 'Hazard Analysis Report',
|
|
35
|
+
standards: ['ISO 14971:2019 §5', 'ISO 14971:2019 §6'],
|
|
36
|
+
layers: ['risk'],
|
|
37
|
+
relevantKinds: ['Hazard', 'HazardousSituation', 'Harm', 'RiskControl'],
|
|
38
|
+
relevantRelationships: ['mitigates', 'causedBy', 'leadsTo', 'identifiedIn'],
|
|
39
|
+
group: 'risk',
|
|
40
|
+
sections: [
|
|
41
|
+
{ id: 'hazard-identification', title: 'Hazard Identification', required: true },
|
|
42
|
+
{ id: 'risk-estimation', title: 'Risk Estimation', required: true },
|
|
43
|
+
{ id: 'risk-evaluation', title: 'Risk Evaluation', required: true },
|
|
44
|
+
{ id: 'risk-controls', title: 'Risk Control Measures', required: true },
|
|
45
|
+
{ id: 'residual-risk', title: 'Residual Risk Assessment', required: true },
|
|
46
|
+
],
|
|
47
|
+
},
|
|
48
|
+
{
|
|
49
|
+
id: 'fmea',
|
|
50
|
+
title: 'Failure Mode and Effects Analysis',
|
|
51
|
+
standards: ['IEC 60812:2018'],
|
|
52
|
+
layers: ['risk', 'functional', 'physical'],
|
|
53
|
+
relevantKinds: ['Hazard', 'RiskControl', 'Function', 'Component', 'Subsystem'],
|
|
54
|
+
relevantRelationships: ['mitigates', 'allocatedTo', 'performs'],
|
|
55
|
+
group: 'risk',
|
|
56
|
+
sections: [
|
|
57
|
+
{ id: 'scope', title: 'FMEA Scope & Boundaries', required: true },
|
|
58
|
+
{ id: 'function-analysis', title: 'Function Analysis', required: true },
|
|
59
|
+
{ id: 'failure-modes', title: 'Failure Mode Identification', required: true },
|
|
60
|
+
{ id: 'effects-analysis', title: 'Effects Analysis', required: true },
|
|
61
|
+
{ id: 'risk-priority', title: 'Risk Priority Numbers', required: true },
|
|
62
|
+
{ id: 'actions', title: 'Recommended Actions', required: false },
|
|
63
|
+
],
|
|
64
|
+
},
|
|
65
|
+
// ─── Traceability ────────────────────────────────────────────────────
|
|
66
|
+
{
|
|
67
|
+
id: 'rtm',
|
|
68
|
+
title: 'Requirements Traceability Matrix',
|
|
69
|
+
standards: ['IEC 62304:2006 §5.1.1', 'ISO 13485:2016 §7.3.3'],
|
|
70
|
+
layers: ['requirements', 'functional', 'verification'],
|
|
71
|
+
relevantKinds: ['Requirement', 'Requirement', 'DesignInput', 'DesignOutput', 'TestCase', 'VerificationActivity'],
|
|
72
|
+
relevantRelationships: ['traceTo', 'satisfies', 'verifies', 'derivedFrom'],
|
|
73
|
+
group: 'design',
|
|
74
|
+
sections: [
|
|
75
|
+
{ id: 'requirements-list', title: 'Requirements Inventory', required: true },
|
|
76
|
+
{ id: 'design-trace', title: 'Requirements → Design Traceability', required: true },
|
|
77
|
+
{ id: 'verification-trace', title: 'Requirements → Verification Traceability', required: true },
|
|
78
|
+
{ id: 'coverage-summary', title: 'Coverage Summary', required: true },
|
|
79
|
+
{ id: 'gaps', title: 'Traceability Gaps', required: false },
|
|
80
|
+
],
|
|
81
|
+
},
|
|
82
|
+
// ─── Architecture ────────────────────────────────────────────────────
|
|
83
|
+
{
|
|
84
|
+
id: 'sad',
|
|
85
|
+
title: 'System Architecture Description',
|
|
86
|
+
standards: ['ISO/IEC/IEEE 42010:2022', 'IEC 62304:2006 §5.3'],
|
|
87
|
+
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 },
|
|
95
|
+
{ 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
|
+
},
|
|
100
|
+
{
|
|
101
|
+
id: 'sds',
|
|
102
|
+
title: 'Software Design Specification',
|
|
103
|
+
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 },
|
|
110
|
+
{ id: 'interfaces', title: 'Software Interfaces', required: true },
|
|
111
|
+
{ id: 'soup', title: 'SOUP Components', required: true },
|
|
112
|
+
{ id: 'decomposition', title: 'Software Decomposition', required: true },
|
|
113
|
+
],
|
|
114
|
+
},
|
|
115
|
+
{
|
|
116
|
+
id: 'soup',
|
|
117
|
+
title: 'SOUP List (Software of Unknown Provenance)',
|
|
118
|
+
standards: ['IEC 62304:2006 §8.1.2'],
|
|
119
|
+
layers: ['software'],
|
|
120
|
+
relevantKinds: ['SOUPComponent'],
|
|
121
|
+
relevantRelationships: ['dependsOn', 'usedBy'],
|
|
122
|
+
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 },
|
|
127
|
+
],
|
|
128
|
+
},
|
|
129
|
+
// ─── Design Control ──────────────────────────────────────────────────
|
|
130
|
+
{
|
|
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'],
|
|
137
|
+
group: 'design',
|
|
138
|
+
sections: [
|
|
139
|
+
{ id: 'stakeholder-needs', title: 'Stakeholder Needs', required: true },
|
|
140
|
+
{ id: 'design-inputs', title: 'Design Inputs', required: true },
|
|
141
|
+
{ id: 'trace-to-needs', title: 'Input-to-Need Traceability', required: true },
|
|
142
|
+
],
|
|
143
|
+
},
|
|
144
|
+
{
|
|
145
|
+
id: 'dop',
|
|
146
|
+
title: 'Design Output Plan',
|
|
147
|
+
standards: ['ISO 13485:2016 §7.3.4'],
|
|
148
|
+
layers: ['functional', 'physical', 'software'],
|
|
149
|
+
relevantKinds: ['DesignOutput', 'Component', 'SoftwareItem', 'Function'],
|
|
150
|
+
relevantRelationships: ['satisfies', 'implements', 'allocatedTo'],
|
|
151
|
+
group: 'design',
|
|
152
|
+
sections: [
|
|
153
|
+
{ id: 'design-outputs', title: 'Design Outputs', required: true },
|
|
154
|
+
{ id: 'output-to-input', title: 'Output-to-Input Traceability', required: true },
|
|
155
|
+
],
|
|
156
|
+
},
|
|
157
|
+
// ─── Verification & Validation ───────────────────────────────────────
|
|
158
|
+
{
|
|
159
|
+
id: 'vvp',
|
|
160
|
+
title: 'Verification & Validation Plan',
|
|
161
|
+
standards: ['ISO 13485:2016 §7.3.6', 'IEC 62304:2006 §5.7'],
|
|
162
|
+
layers: ['verification'],
|
|
163
|
+
relevantKinds: ['TestCase', 'VerificationActivity', 'ValidationActivity', 'TestProtocol'],
|
|
164
|
+
relevantRelationships: ['verifies', 'validates', 'traceTo'],
|
|
165
|
+
group: 'verification',
|
|
166
|
+
sections: [
|
|
167
|
+
{ id: 'verification-strategy', title: 'Verification Strategy', required: true },
|
|
168
|
+
{ id: 'test-cases', title: 'Test Cases', required: true },
|
|
169
|
+
{ id: 'acceptance-criteria', title: 'Acceptance Criteria', required: true },
|
|
170
|
+
{ id: 'validation-plan', title: 'Validation Plan', required: false },
|
|
171
|
+
],
|
|
172
|
+
},
|
|
173
|
+
{
|
|
174
|
+
id: 'vvr',
|
|
175
|
+
title: 'Verification & Validation Report',
|
|
176
|
+
standards: ['ISO 13485:2016 §7.3.7', 'IEC 62304:2006 §5.8'],
|
|
177
|
+
layers: ['verification'],
|
|
178
|
+
relevantKinds: ['TestCase', 'VerificationActivity', 'ValidationActivity', 'TestResult'],
|
|
179
|
+
relevantRelationships: ['verifies', 'validates', 'traceTo'],
|
|
180
|
+
group: 'verification',
|
|
181
|
+
sections: [
|
|
182
|
+
{ id: 'results-summary', title: 'Results Summary', required: true },
|
|
183
|
+
{ id: 'test-results', title: 'Test Results', required: true },
|
|
184
|
+
{ id: 'deviations', title: 'Deviations & Non-Conformances', required: false },
|
|
185
|
+
{ id: 'conclusion', title: 'Conclusion', required: true },
|
|
186
|
+
],
|
|
187
|
+
},
|
|
188
|
+
// ─── Compliance ──────────────────────────────────────────────────────
|
|
189
|
+
{
|
|
190
|
+
id: 'sdp',
|
|
191
|
+
title: 'Software Development Plan',
|
|
192
|
+
standards: ['IEC 62304:2006 §5.1'],
|
|
193
|
+
layers: ['software', 'verification'],
|
|
194
|
+
relevantKinds: ['SoftwareItem', 'SoftwareUnit', 'SoftwareSystem', 'TestCase'],
|
|
195
|
+
relevantRelationships: ['composedOf', 'verifies', 'implements'],
|
|
196
|
+
group: 'compliance',
|
|
197
|
+
sections: [
|
|
198
|
+
{ id: 'scope', title: 'Scope & Software Safety Class', required: true },
|
|
199
|
+
{ id: 'lifecycle', title: 'Software Development Life Cycle', required: true },
|
|
200
|
+
{ id: 'deliverables', title: 'Deliverables', required: true },
|
|
201
|
+
{ id: 'tools', title: 'Development Tools & Environment', required: false },
|
|
202
|
+
],
|
|
203
|
+
},
|
|
204
|
+
{
|
|
205
|
+
id: 'csr',
|
|
206
|
+
title: 'Clinical Safety Report',
|
|
207
|
+
standards: ['ISO 14971:2019 §10'],
|
|
208
|
+
layers: ['risk', 'verification'],
|
|
209
|
+
relevantKinds: ['Hazard', 'RiskControl', 'ClinicalEvidence', 'ValidationActivity'],
|
|
210
|
+
relevantRelationships: ['mitigates', 'validates', 'supports'],
|
|
211
|
+
group: 'compliance',
|
|
212
|
+
sections: [
|
|
213
|
+
{ id: 'safety-summary', title: 'Safety Summary', required: true },
|
|
214
|
+
{ id: 'risk-benefit', title: 'Risk-Benefit Analysis', required: true },
|
|
215
|
+
{ id: 'post-market', title: 'Post-Market Surveillance Plan', required: false },
|
|
216
|
+
],
|
|
217
|
+
},
|
|
218
|
+
{
|
|
219
|
+
id: 'uer',
|
|
220
|
+
title: 'Usability Engineering Report',
|
|
221
|
+
standards: ['IEC 62366-1:2015'],
|
|
222
|
+
layers: ['ui', 'requirements'],
|
|
223
|
+
relevantKinds: ['UseCase', 'UserActivity', 'UserInterface', 'UsabilityRequirement'],
|
|
224
|
+
relevantRelationships: ['performs', 'interactsWith', 'satisfies'],
|
|
225
|
+
group: 'compliance',
|
|
226
|
+
sections: [
|
|
227
|
+
{ id: 'use-specification', title: 'Use Specification', required: true },
|
|
228
|
+
{ id: 'use-scenarios', title: 'Use Scenarios', required: true },
|
|
229
|
+
{ id: 'hazard-related-use', title: 'Hazard-Related Use Scenarios', required: true },
|
|
230
|
+
{ id: 'evaluation', title: 'Usability Evaluation', required: false },
|
|
231
|
+
],
|
|
232
|
+
},
|
|
233
|
+
{
|
|
234
|
+
id: 'cybersecurity',
|
|
235
|
+
title: 'Cybersecurity Documentation',
|
|
236
|
+
standards: ['IEC 81001-5-1:2021'],
|
|
237
|
+
layers: ['software', 'interfaces'],
|
|
238
|
+
relevantKinds: ['ThreatModel', 'SecurityControl', 'Interface', 'SOUPComponent'],
|
|
239
|
+
relevantRelationships: ['mitigates', 'connectedTo', 'dependsOn'],
|
|
240
|
+
group: 'compliance',
|
|
241
|
+
sections: [
|
|
242
|
+
{ id: 'threat-model', title: 'Threat Model', required: true },
|
|
243
|
+
{ id: 'security-controls', title: 'Security Controls', required: true },
|
|
244
|
+
{ id: 'vulnerability-assessment', title: 'Vulnerability Assessment', required: false },
|
|
245
|
+
],
|
|
246
|
+
},
|
|
247
|
+
{
|
|
248
|
+
id: 'labeling',
|
|
249
|
+
title: 'Labeling Specification',
|
|
250
|
+
standards: ['21 CFR 801', 'MDR Annex I §23'],
|
|
251
|
+
layers: ['requirements', 'ui'],
|
|
252
|
+
relevantKinds: ['LabelingRequirement', 'Requirement'],
|
|
253
|
+
relevantRelationships: ['traceTo', 'satisfies'],
|
|
254
|
+
group: 'compliance',
|
|
255
|
+
sections: [
|
|
256
|
+
{ id: 'label-content', title: 'Label Content Requirements', required: true },
|
|
257
|
+
{ id: 'ifu', title: 'Instructions for Use', required: true },
|
|
258
|
+
{ id: 'udi', title: 'Unique Device Identification', required: false },
|
|
259
|
+
],
|
|
260
|
+
},
|
|
261
|
+
{
|
|
262
|
+
id: 'dhf-index',
|
|
263
|
+
title: 'Design History File Index',
|
|
264
|
+
standards: ['ISO 13485:2016 §4.2.4', '21 CFR 820.30'],
|
|
265
|
+
layers: [],
|
|
266
|
+
relevantKinds: [],
|
|
267
|
+
relevantRelationships: [],
|
|
268
|
+
group: 'all',
|
|
269
|
+
sections: [
|
|
270
|
+
{ id: 'document-list', title: 'Document Inventory', required: true },
|
|
271
|
+
{ id: 'status-summary', title: 'Status Summary', required: true },
|
|
272
|
+
{ id: 'completeness', title: 'Completeness Overview', required: true },
|
|
273
|
+
{ id: 'approvals', title: 'Approval History', required: false },
|
|
274
|
+
],
|
|
275
|
+
},
|
|
276
|
+
{
|
|
277
|
+
id: 'change-log',
|
|
278
|
+
title: 'Design Change Log',
|
|
279
|
+
standards: ['ISO 13485:2016 §7.3.9'],
|
|
280
|
+
layers: [],
|
|
281
|
+
relevantKinds: [],
|
|
282
|
+
relevantRelationships: [],
|
|
283
|
+
group: 'all',
|
|
284
|
+
sections: [
|
|
285
|
+
{ id: 'changes', title: 'Change History', required: true },
|
|
286
|
+
{ id: 'impact-assessment', title: 'Impact Assessment', required: false },
|
|
287
|
+
{ id: 'approvals', title: 'Change Approvals', required: false },
|
|
288
|
+
],
|
|
289
|
+
},
|
|
290
|
+
];
|
|
291
|
+
/** Get a document type by ID */
|
|
292
|
+
export function getDocumentType(id) {
|
|
293
|
+
return DHF_DOCUMENT_TYPES.find(d => d.id === id);
|
|
294
|
+
}
|
|
295
|
+
/** Get all document types in a group */
|
|
296
|
+
export function getDocumentsByGroup(group) {
|
|
297
|
+
if (group === 'all')
|
|
298
|
+
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',
|
|
313
|
+
TestProtocol: 'vvp',
|
|
314
|
+
TestReport: 'vvr',
|
|
315
|
+
EvidenceRecord: 'dhf-index',
|
|
316
|
+
CybersecurityAssessmentReport: 'cybersecurity',
|
|
317
|
+
ThreatModelReport: 'cybersecurity',
|
|
318
|
+
UsabilityEngineeringReport: 'uer',
|
|
319
|
+
ClinicalSafetyReport: 'csr',
|
|
320
|
+
FailureModeEffectsAnalysisReport: 'fmea',
|
|
321
|
+
SoupList: 'soup',
|
|
322
|
+
DesignInputPlan: 'dip',
|
|
323
|
+
DesignOutputPlan: 'dop',
|
|
324
|
+
SoftwareDevelopmentPlan: 'sdp',
|
|
325
|
+
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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