---
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** : `DQBggqFNWsRNTPb6kkiwppnMo1Hm8edfWq`


---
Source attribution: modbender
Original project: https://github.com/modbender/skill-library-mcp/blob/d9c8fe903b5b4e82237dbe8d0df8567783022e18/data/firm-medtech-pack/SKILL.md
License: MIT
License information: https://opensource.org/license/mit
Original upstream instructions; downloaded from Mega AI Hub.

## Upstream license notice

MIT License

Copyright (c) 2025 skill-library-mcp contributors

Permission is hereby granted, free of charge, to any person obtaining a copy
of this software and associated documentation files (the "Software"), to deal
in the Software without restriction, including without limitation the rights
to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
copies of the Software, and to permit persons to whom the Software is
furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all
copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
SOFTWARE.



# Mega AI Hub resource metadata

Creator / publisher: modbender
Original project: https://github.com/modbender/skill-library-mcp/blob/d9c8fe903b5b4e82237dbe8d0df8567783022e18/data/firm-medtech-pack/SKILL.md
Attribution basis: Source repository record

Fields of work: Healthcare & Life Sciences, Marketing
Roles: Clinical Research, Growth Marketer, Marketing Analyst, Medical Writer, Product Marketer
Specialties: API
Tools: OpenAI API, Clawhub
Country applicability: Country not specified
Classification basis: Source catalog labels
Instruction SHA-256: f1f195e9af8a32ced9bf984262ceba7f807f5cad26d62e66b2f393f49d060a28