概述

firm-medtech-pack

Sector bundle for medical technology & digital health environments.

Activated departments

Department	Services activated	Focus
---	---	---
RA	Regulatory Affairs · Compliance Legal	FDA 510(k), CE Marking, MDR
Research Development	Research Discovery · R&D Prototyping	Clinical evidence, biomarker research
Quality	Compliance Auditing · Reliability · Security	ISO 13485, IEC 62304
Legal	Privacy/Data Protection · IP	HIPAA, patient data, patents
Operations	Documentation · SRE/Incident	DHF, adverse event reporting

Recommended ClawHub skills to install alongside

npx clawhub@latest install academic-research        # PubMed / clinical trial search
npx clawhub@latest install admet-prediction         # Drug candidate ADMET analysis
npx clawhub@latest install pdf-documents            # Clinical study PDF parsing
npx clawhub@latest install arc-security-audit       # 21 CFR Part 11 audit trail
npx clawhub@latest install firm-orchestration       # A2A orchestration backbone

Firm configuration overlay

{
  "agent": {
    "model": "anthropic/claude-opus-4-6",
    "workspace": "~/.openclaw/workspace/medtech-firm"
  },
  "agents": {
    "defaults": {
      "sandbox": { "mode": "non-main" }
    }
  }
}

Prompt: regulatory submission prep

Use firm-orchestration with:
  objective: "Prepare 510(k) substantial equivalence summary for continuous glucose monitor"
  departments: ["ra", "research_development", "quality"]
  constraints: ["FDA guidance K020431 reference", "predicate device: Dexcom G6"]
  definition_of_done: "510(k) summary draft with predicate comparison table"
  delivery_format: "structured_document"

Prompt: adverse event review

Use firm-orchestration with:
  objective: "Classify and triage Q4 adverse event reports against MDR Art. 87"
  departments: ["ra", "quality", "legal"]
  constraints: ["read-only access", "anonymize patient identifiers in output"]
  definition_of_done: "Triage matrix with reportability decisions per event"
  delivery_format: "markdown_report"

Regulatory coverage

Standard	Department	Service
---	---	---
FDA 510(k) / PMA	RA	Regulatory Affairs
EU MDR 2017/745	RA + Legal	Regulatory + Privacy
ISO 13485:2016	Quality	Compliance Auditing
IEC 62304	Engineering	AI Engineering
HIPAA	Legal	Privacy/Data Protection
21 CFR Part 11	Quality	Security
ISO 14971	RA + Quality	Risk Management

Security notes

PHI (Protected Health Information): SECURE_PRODUCTION_MODE=true mandatory
All outputs must be anonymized: enforce via POLICY_BLOCKED_TOOLS for export
Audit trail required by 21 CFR Part 11: AUDIT_ENABLED=true

💎 Support

Si ce skill vous est utile, vous pouvez soutenir le développement :

Dogecoin : DQBggqFNWsRNTPb6kkiwppnMo1Hm8edfWq

版本历史

共 1 个版本

v1.0.0 当前

2026-03-30 02:54 安全安全

安全检测

腾讯云安全 (Keen)

安全，无风险

查看报告

腾讯云安全 (Sanbu)