@neobiotechlabs/neobiotech-dev-agent 0.1.18 → 0.1.20

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": "0.1.20"
       },
       "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": "0.1.20",
   "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