dvcrn 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=truemandatory - All outputs must be anonymized: enforce via
POLICY_BLOCKED_TOOLSfor export - Audit trail required by 21 CFR Part 11:
AUDIT_ENABLED=true
💎 Support
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