Skill: romainsantoli-web/firm-medtech-pack (version 1.0.0)

--- 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 --- # 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 ```bash 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 ```json { "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** : [REDACTED_SECRET]


Security scan verdicts — ClawScan: clean | static analysis: clean | VirusTotal: suspicious | SkillSpector: clean (LOW)