@neobiotechlabs/neobiotech-dev-agent 0.1.18 → 0.1.19

package/.claude-plugin/marketplace.json

@@ -10,7 +10,7 @@
         "source": "npm",
         "package": "@neobiotechlabs/neobiotech-dev-agent",
         "registry": "https://registry.npmjs.org",
-        "version": "0.1.18"
+        "version": "0.1.19"
       },
       "description": "의료기기 SW 규제 개발 자동화 (Jira·Confluence·Risk·CVSS·Xray·IEC 62304/62366·MDR·문서 렌더)",
       "category": "medical-device",

package/.claude-plugin/plugin.json

@@ -1,6 +1,6 @@
 {
   "name": "neobiotech-dev-agent",
-  "version": "0.1.18",
+  "version": "0.1.19",
   "displayName": "NeoBiotech Dev Agent (MedDev)",
   "description": "의료기기 SW 규제 개발 자동화 — Jira·Confluence·Risk·CVSS·Xray·IEC 62304/62366·MDR·문서 렌더",
   "author": {

package/README.md

@@ -413,7 +413,7 @@ PA Gate
       └── Use Scenario ── Relates ──→ Use Spec
             └── Abnormal Use Scenario ── Risk Source ──→ Hazard
 
-EA Gate
+EA Gate (8 living documents — EA 초기 결정·승인 / ER 개발·검증 중 갱신 / CA 최종 확정)
 ├── [Risk Management Report] ── Blocks ──→ Gate
 │     └── Hazard ── Risk Source ──→ IU/SyRS / Use Scenario
 │     └── Hazard ── Relates ──→ RMR Document
@@ -422,11 +422,13 @@ EA Gate
 │     └── Requirement ── Implements ──→ System Requirement
 ├── [SW Architecture Document] ── Blocks ──→ Gate
 │     └── Architecture ── Implements ──→ Requirement
-└── [SW Detailed Design Document] ── Blocks ──→ Gate
-      └── Detailed Design ── Implements ──→ Requirement
-      └── Detailed Design ── Implements ──→ Architecture
-      └── Task ── Implements ──→ Detailed Design
-      └── 선행 Task ── Blocks ──→ 후행 Task
+├── [SW Detailed Design Document] ── Blocks ──→ Gate
+│     └── Detailed Design ── Implements ──→ Requirement/Architecture
+│     └── Task ── Implements ──→ Detailed Design
+├── [SOUP List] ── Blocks ──→ Gate (doc_render; CA 최종 SBOM 기반 확정)
+├── [Usability Evaluation Plan] ── Blocks ──→ Gate (doc_render; use_spec/scenarios 연계)
+├── [Clinical Evaluation Plan] ── Blocks ──→ Gate (doc_render)
+└── [List of Hazard-Related Use Scenarios] ── Blocks ──→ Gate (abnormal scenarios 연계)
 ```
 
 ## 릴리즈 절차

package/dist/index.js

@@ -160549,14 +160549,18 @@ var EA_DOCUMENTS = [
   "[Risk Management Report]",
   "[SW Requirements Specification]",
   "[SW Architecture Document]",
-  "[SW Detailed Design Document]"
+  "[SW Detailed Design Document]",
+  "[SOUP List]",
+  "[Usability Evaluation Plan]",
+  "[Clinical Evaluation Plan]",
+  "[List of Hazard-Related Use Scenarios]"
 ];
 var LINK_GUIDE = '\n\nIMPORTANT - Link type rules:\n\u2022 Document \u2192 Gate: jira_create_link("Blocks", gateKey, documentKey) \u2014 Document blocks Gate\n\u2022 Sub-ticket \u2192 Document: jira_create_link("Relates", documentKey, subTicketKey) \u2014 Relates is bidirectional\n\u2022 Hazard \u2192 IU/SyRS: jira_create_link("Risk Source", hazardKey, syrsKey) \u2014 SyRS gives rise to Hazard\n\u2022 Requirement \u2192 Hazard: jira_create_link("Mitigates", requirementKey, hazardKey) \u2014 Requirement mitigates Hazard\n\u2022 Requirement \u2192 System Requirement: jira_create_link("Implements", requirementKey, syrsKey)\n\u2022 Architecture \u2192 Requirement: jira_create_link("Implements", architectureKey, requirementKey)\n\u2022 Detailed Design \u2192 Requirement/Architecture: jira_create_link("Implements", ddKey, targetKey)\n\u2022 Task \u2192 Detailed Design: jira_create_link("Implements", taskKey, ddKey)\n\u2022 \uC120\uD589 Task \u2192 \uD6C4\uD589 Task: jira_create_link("Blocks", \uD6C4\uD589taskKey, \uC120\uD589taskKey) \u2014 \uC120\uD589\uC774 \uD6C4\uD589\uC744 block\n\nIMPORTANT - Git commit message rules:\n\u2022 Every commit MUST start with the Jira ticket key: "SCW-xxx type: message"\n\u2022 Example: "SCW-77 feat: set up project scaffold and dev environment"\n\u2022 Multiple tickets: "SCW-30 SCW-69 chore: add dental 3D scan test files"\n\u2022 This enables Jira to auto-link commits to tickets\n\u2022 Commit after each meaningful change (document written, task completed, bug fixed)\n\u2022 Push after each commit or group of related commits\n\nIMPORTANT - Scope of action rules:\n\u2022 "\uAC8C\uC774\uD2B8 \uB9CC\uB4E4\uC5B4" \u2192 ONLY create the Gate. Do NOT create Document tickets.\n\u2022 "\uBB38\uC11C \uB9CC\uB4E4\uC5B4" \u2192 ONLY create the specified Documents. Do NOT create sub-tickets.\n\u2022 Do NOT chain-create beyond what the user explicitly asked for.\n\u2022 When in doubt, ask the user before creating additional items.\n\nIMPORTANT - Ticket creation rules:\n\u2022 Before creating a ticket, search JQL for existing similar tickets to avoid duplicates.\n\u2022 Bug description format: \u{1F629} Problem \u2192 \u{1F50E} Root Cause \u2192 \u{1F527} Fix \u2192 \u{1F41B} Reproduction\n\u2022 Task/Feature description format: \u{1F3AF} Goal \u2192 \u{1F4CB} Tasks \u2192 \u2705 Acceptance Criteria\n\u2022 Do NOT auto-transition ticket status (e.g. In Progress \u2192 Done) unless explicitly asked.\n\u2022 When creating 3+ tickets at once, show the plan first and wait for user approval.\n\nIMPORTANT - Commit-ticket linking:\n\u2022 After pushing commits, verify the ticket has the commit linked (auto-linked via ticket key in message).\n\u2022 If commits are not linked, add a comment to the ticket with the commit details.';
 var registerIecTools = (ctx2) => {
   const { server: server2, jira: jira2 } = ctx2;
   server2.tool("iec_create_gate", "Create a PA or EA Gate with all required Document tickets and Blocks links. Based on IEC 62304 lifecycle.", {
     project_key: external_exports.string().describe("Project key"),
-    phase: external_exports.enum(["PA", "EA"]).describe("Phase: PA (7 documents) or EA (4 documents)"),
+    phase: external_exports.enum(["PA", "EA"]).describe("Phase: PA (7 documents) or EA (8 documents)"),
     gate_summary: external_exports.string().optional().describe('Gate summary (default: "PA Gate" or "EA Gate")')
   }, async ({ project_key, phase, gate_summary }) => {
     const summary = gate_summary || `${phase} Gate`;
@@ -160604,10 +160608,15 @@ var registerIecTools = (ctx2) => {
         steps.push("[Classification] \u2192 Create 1 Classification ticket, link with Relates");
         steps.push("[Risk Management Plan] through [Configuration Management Plan] \u2192 Generate document content");
       } else if (summary.includes("EA")) {
-        steps.push("[Risk Management Report] \u2192 Use risk_create_hazards to create Hazard tickets");
-        steps.push("[SW Requirements Spec] \u2192 Organize FR/NFR, use risk_create_mitigation to create Requirements");
-        steps.push("[SW Architecture Document] \u2192 Create Architecture Design tickets (architecture decisions, tech stack, deployment)");
-        steps.push("[SW Detailed Design Document] \u2192 Create Detailed Design tickets referencing SRS + SAD, then bottom-up Tasks");
+        steps.push("EA Gate \u2014 8\uAC1C living documents (EA \uCD08\uAE30 \uACB0\uC815\xB7\uC2B9\uC778 \u2192 ER \uAC1C\uBC1C\xB7\uAC80\uC99D \uC911 \uAC31\uC2E0 \u2192 CA \uCD5C\uC885 \uD655\uC815).");
+        steps.push("[Risk Management Report] \u2192 risk_create_hazards (FMEA \uC704\uD5D8 \uC2DD\uBCC4; \uC0C8 \uC704\uD5D8\xB7\uD1B5\uC81C \uCD94\uAC00 \uC2DC \uAC31\uC2E0)");
+        steps.push("[SW Requirements Spec] \u2192 FR/NFR \uC815\uB9AC + risk_create_mitigation (\uC694\uAD6C\uC0AC\uD56D \uBCC0\uACBD\xB7\uCD94\uAC00 \uC2DC \uAC31\uC2E0)");
+        steps.push("[SW Architecture Document] \u2192 \uC544\uD0A4\uD14D\uCC98 \uACB0\uC815 \uD2F0\uCF13 (\uBCC0\uACBD\xB7\uC0C1\uC138\uD654 \uC2DC \uAC31\uC2E0)");
+        steps.push("[SW Detailed Design Document] \u2192 \uC720\uB2DB \uC0C1\uC138\uC124\uACC4 \uD2F0\uCF13 + bottom-up Tasks (sprint\uB9C8\uB2E4 \uC720\uB2DB \uCD94\uAC00\xB7\uC0C1\uC138\uD654 \uC2DC \uAC31\uC2E0)");
+        steps.push("[SOUP List] \u2192 SOUP \uC2DD\uBCC4 (\uC2E4\uC81C \uC758\uC874\uC131 \uCD94\uAC00/\uC81C\uAC70/\uBC84\uC804\uC5C5 \uC2DC \uAC31\uC2E0; CA \uCD5C\uC885 SBOM \uAE30\uBC18 \uD655\uC815)");
+        steps.push("[Usability Evaluation Plan] \u2192 \uC0AC\uC6A9\uC131 \uD3C9\uAC00 \uACC4\uD68D (\uD3C9\uAC00 \uACB0\uACFC \uBC18\uC601\xB7\uACC4\uD68D \uC870\uC815 \uC2DC \uAC31\uC2E0)");
+        steps.push("[Clinical Evaluation Plan] \u2192 \uC784\uC0C1 \uD3C9\uAC00 \uACC4\uD68D (\uD3C9\uAC00 \uACB0\uACFC \uBC18\uC601\xB7\uACC4\uD68D \uC870\uC815 \uC2DC \uAC31\uC2E0)");
+        steps.push("[List of Hazard-Related Use Scenarios] \u2192 \uC704\uD5D8 \uAD00\uB828 \uC0AC\uC6A9 \uC2DC\uB098\uB9AC\uC624 \uC2DD\uBCC4 (\uC0C8 \uC2DC\uB098\uB9AC\uC624 \uC2DD\uBCC4 \uC2DC \uAC31\uC2E0)");
       }
     } else if (type === "Document") {
       if (summary.includes("Intended Use")) {
@@ -160639,6 +160648,17 @@ var registerIecTools = (ctx2) => {
         steps.push("Include: component interfaces, algorithms, data structures, API specs");
         steps.push('Link: jira_create_link("Implements", ddKey, architectureKey) and jira_create_link("Implements", ddKey, requirementKey)');
         steps.push('Also link: jira_create_link("Relates", thisDocumentKey, ddKey)');
+      } else if (summary.includes("SOUP")) {
+        steps.push('\uC2DD\uBCC4\uB41C SOUP(third-party \uC758\uC874\uC131) \uBAA9\uB85D\uD654 \u2014 doc_render(template="soup_list")\uB85C \uB80C\uB354');
+        steps.push("CA \uCD5C\uC885 \uD655\uC815 \uC804\uAE4C\uC9C0 \uC758\uC874\uC131 \uBCC0\uACBD(\uCD94\uAC00/\uC81C\uAC70/\uBC84\uC804\uC5C5)\uB9C8\uB2E4 \uAC31\uC2E0");
+      } else if (summary.includes("Usability Evaluation Plan")) {
+        steps.push("\uC0AC\uC6A9\uC131 \uD3C9\uAC00 \uACC4\uD68D \uC218\uB9BD \u2014 usability_create_use_spec / usability_create_scenarios\uC640 \uC5F0\uACC4");
+        steps.push('doc_render(template="usability_evaluation_plan")\uB85C \uB80C\uB354');
+      } else if (summary.includes("Clinical Evaluation Plan")) {
+        steps.push('\uC784\uC0C1 \uD3C9\uAC00 \uACC4\uD68D \uC218\uB9BD \u2014 doc_render(template="clinical_evaluation_plan")\uB85C \uB80C\uB354');
+      } else if (summary.includes("Hazard-Related")) {
+        steps.push('\uC704\uD5D8 \uAD00\uB828 \uC0AC\uC6A9 \uC2DC\uB098\uB9AC\uC624 \uC2DD\uBCC4 \u2014 usability_create_scenarios(type="abnormal")\uC640 \uC5F0\uACC4');
+        steps.push('doc_render(template="list_of_hazard_related_use_scenarios")\uB85C \uB80C\uB354');
       } else {
         steps.push("Generate document content based on referenced sources");
         steps.push("Use doc_update_description to update the ticket");
@@ -160787,21 +160807,32 @@ var WORKFLOWS = {
   ea: [
     "=== EA Gate \uC6CC\uD06C\uD50C\uB85C\uC6B0 ===",
     "",
-    "1. iec_create_gate \u2192 EA Gate + 4\uAC1C Document \uD2F0\uCF13 \uC0DD\uC131",
-    "2. [Risk Management Report]",
-    "   - risk_create_hazards \u2192 Hazard \uC77C\uAD04 \uC0DD\uC131",
-    "   - usability_link_to_hazard \u2192 \uC0AC\uC6A9 \uC2DC\uB098\uB9AC\uC624 \u2192 Hazard \uC5F0\uACB0",
-    "3. [SW Requirements Spec]",
-    "   - FR/NFR \uC815\uB9AC",
-    "   - risk_create_mitigation \u2192 \uC644\uD654 Requirement \uC0DD\uC131 + P2 \uC5C5\uB370\uC774\uD2B8",
-    "4. [SW Architecture Document] \u2192 \uC544\uD0A4\uD14D\uCC98 \uC124\uACC4",
-    "5. [SW Detailed Design Document] \u2192 \uC0C1\uC138 \uC124\uACC4 + Task \uC0DD\uC131",
+    "1. iec_create_gate \u2192 EA Gate + 8\uAC1C Document \uD2F0\uCF13 \uC0DD\uC131 (living documents)",
+    "2. [Risk Management Report] \u2192 risk_create_hazards (FMEA) + usability_link_to_hazard",
+    "3. [SW Requirements Spec] \u2192 FR/NFR \uC815\uB9AC + risk_create_mitigation",
+    "4. [SW Architecture Document] \u2192 \uC544\uD0A4\uD14D\uCC98 \uACB0\uC815",
+    "5. [SW Detailed Design Document] \u2192 \uC720\uB2DB \uC0C1\uC138\uC124\uACC4 + bottom-up Tasks",
+    "6. [SOUP List] \u2192 doc_render(soup_list)",
+    "7. [Usability Evaluation Plan] \u2192 usability_create_use_spec/scenarios \uC5F0\uACC4 + doc_render",
+    "8. [Clinical Evaluation Plan] \u2192 doc_render(clinical_evaluation_plan)",
+    "9. [List of Hazard-Related Use Scenarios] \u2192 usability_create_scenarios(abnormal) \uC5F0\uACC4",
+    "",
+    "EA 8\uAC1C \uBB38\uC11C = living document (IEC 62304 evolutionary \uBAA8\uB378):",
+    "  \u2022 EA: \uCD08\uAE30 \uACB0\uC815\xB7\uC2B9\uC778 / ER: \uAC1C\uBC1C\xB7\uAC80\uC99D \uC911 \uAC31\uC2E0 / CA: \uCD5C\uC885 \uD655\uC815",
+    "  \u2022 \uAC31\uC2E0 \uD2B8\uB9AC\uAC70:",
+    "    - SRS: \uC694\uAD6C\uC0AC\uD56D \uBCC0\uACBD/\uCD94\uAC00 (change-evaluation-list \uC5F0\uACC4)",
+    "    - SAD: \uC544\uD0A4\uD14D\uCC98 \uBCC0\uACBD/\uC0C1\uC138\uD654 (architecture-checklist)",
+    "    - SDD: sprint \uC720\uB2DB \uCD94\uAC00/\uC0C1\uC138\uD654",
+    "    - FMEA Risk Table: \uC0C8 \uC704\uD5D8\xB7\uD1B5\uC81C \uC2DD\uBCC4 (hazard \uCD94\uAC00)",
+    "    - SOUP List: \uC758\uC874\uC131 \uBCC0\uACBD (\u2192 CA \uCD5C\uC885 SBOM \uAE30\uBC18 \uD655\uC815)",
+    "    - Usability/Clinical Eval Plan: \uD3C9\uAC00 \uACB0\uACFC \uBC18\uC601\xB7\uACC4\uD68D \uC870\uC815",
+    "    - Hazard-Related Use Scenarios: \uC0C8 \uC2DC\uB098\uB9AC\uC624 \uC2DD\uBCC4",
     "",
     "\uAC80\uC99D:",
-    "6. xray_create_test \u2192 \uD14C\uC2A4\uD2B8 \uCF00\uC774\uC2A4 \uC0DD\uC131",
-    "7. usability_create_validation \u2192 \uC0AC\uC6A9\uC131 \uAC80\uC99D",
-    "8. doc_check_completeness \u2192 \uAE30\uC220 \uBB38\uC11C \uC644\uC804\uC131 \uAC80\uC99D",
-    "9. doc_generate_evidence \u2192 NB \uC2EC\uC0AC\uC6A9 \uC99D\uAC70 \uD328\uD0A4\uC9C0 \uC0DD\uC131"
+    "10. xray_create_test \u2192 \uD14C\uC2A4\uD2B8 \uCF00\uC774\uC2A4 \uC0DD\uC131",
+    "11. usability_create_validation \u2192 \uC0AC\uC6A9\uC131 \uAC80\uC99D",
+    "12. doc_check_completeness \u2192 \uAE30\uC220 \uBB38\uC11C \uC644\uC804\uC131 \uAC80\uC99D",
+    "13. doc_generate_evidence \u2192 NB \uC2EC\uC0AC\uC6A9 \uC99D\uAC70 \uD328\uD0A4\uC9C0 \uC0DD\uC131"
   ].join("\n"),
   risk: [
     "=== \uB9AC\uC2A4\uD06C \uAD00\uB9AC \uC6CC\uD06C\uD50C\uB85C\uC6B0 ===",
@@ -161482,6 +161513,7 @@ var TEMPLATE_PATHS = {
   // mdr_docs — EA gate (IEC 62304 Evolutionary Assessment 산출물)
   software_requirements_list: { path: "mdr_docs/EA/software-requirements-list.md", mode: "freeform", domain: "mdr", gate: "EA" },
   software_architecture_description: { path: "mdr_docs/EA/software-architecture-description.md", mode: "freeform", domain: "mdr", gate: "EA" },
+  software_detailed_design: { path: "mdr_docs/EA/software-detailed-design.md", mode: "freeform", domain: "mdr", gate: "EA" },
   risk_table_fmea: { path: "mdr_docs/EA/risk-table-fmea.md", mode: "freeform", domain: "mdr", gate: "EA" },
   soup_list: { path: "mdr_docs/EA/soup-list.md", mode: "freeform", domain: "mdr", gate: "EA" },
   usability_evaluation_plan: { path: "mdr_docs/EA/usability-evaluation-plan.md", mode: "freeform", domain: "mdr", gate: "EA" },
@@ -161489,7 +161521,7 @@ var TEMPLATE_PATHS = {
   list_of_hazard_related_use_scenarios: { path: "mdr_docs/EA/list-of-hazard-related-use-scenarios.md", mode: "freeform", domain: "mdr", gate: "EA" }
 };
 var TEMPLATE_NAMES = Object.keys(TEMPLATE_PATHS);
-var TEMPLATE_VERSION = "b1dbcb6";
+var TEMPLATE_VERSION = "17d0c4e";
 
 // src/tools/doc-render.ts
 init_adf();
@@ -184691,7 +184723,7 @@ var xrayClientSecret = process.env.XRAY_CLIENT_SECRET || "";
 var xray = xrayClientId && xrayClientSecret ? new XrayClient(xrayClientId, xrayClientSecret, jiraUrl, jiraEmail, jiraToken) : null;
 var server = new McpServer({
   name: "jira-confluence",
-  version: "0.1.18"
+  version: "0.1.19"
 });
 var ctx = { server, jira, confluence, risk, xray };
 registerJiraCrudTools(ctx);