Firm Medtech Pack

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name: firm-medtech-pack version: 1.0.0 description: > Curated skill bundle for medical device companies, digital health startups and pharma R&D teams. Activates the firm pyramid with RA (Regulatory Affairs), Clinical, R&D and Quality agents pre-configured for FDA/CE compliance, clinical documentation and pharmacovigilance workflows. author: romainsantoli-web license: MIT metadata: openclaw: requires: env: [] bins: [] tools: - sessions_send - sessions_spawn - sessions_history primaryEnv: "" tags: - medtech - healthtech - pharma - regulatory - fda - ce-marking - firm-pack - sector

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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

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