A professional-grade skill bundle for medical device and pharmaceutical teams to automate regulatory compliance, clinical documentation, and R&D workflows.
Install & Download
1. ClawHub CLI
The fastest way to install a skill directly from the registry.
npx clawhub@latest install firm-medtech-pack
2. Manual Installation
Copy the skill folder to one of these locations
~/.openclaw/skills/ <project>/skills/ Priority: Workspace > Local > Bundled
3. Prompt Installation
Copy this prompt to OpenClaw to install it automatically.
Help me install firm-medtech-pack using Clawhub. If Clawhub is not installed, install it first (npm i -g clawhub).
Prefer to download?
Get the raw skill files in a ZIP archive.
What is MedTech & Pharma R&D Pack?
The firm-medtech-pack is a specialized sector bundle designed for medical technology, digital health, and pharmaceutical R&D environments. By activating a tiered firm pyramid, it enables cross-departmental AI agents to collaborate on Regulatory Affairs (RA), Clinical Research, and Quality Assurance.
This skill leverages Openclaw Skills to streamline complex workflows like FDA 510(k) submissions and CE Marking, ensuring that technical and legal documentation remains synchronized and compliant with global standards. It bridges the gap between engineering, legal, and clinical teams by providing a unified framework for highly regulated documentation and reporting.
MedTech & Pharma R&D Pack Use Cases
- Drafting 510(k) substantial equivalence summaries and predicate device comparison tables.
- Automating the classification and triage of adverse event reports against MDR Article 87.
- Generating clinical evidence documentation and biomarker research summaries from PubMed.
- Conducting ISO 13485 and IEC 62304 compliance audits for software-as-a-medical-device (SaMD).
- Managing HIPAA-compliant patient data anonymization and 21 CFR Part 11 audit trails.
How MedTech & Pharma R&D Pack Works
- Initializes the MedTech firm hierarchy by spawning specialized agents for RA, R&D, Quality, and Legal departments.
- Connects with academic and clinical data sources using integrated Openclaw Skills to gather peer-reviewed evidence and clinical trial data.
- Processes raw clinical or engineering data through regulatory-aware prompt templates derived from FDA and EU MDR guidance.
- Orchestrates multi-agent reviews where Quality and Legal agents validate the outputs from R&D and RA for compliance.
- Produces structured, anonymized documentation and triage matrices suitable for submission to regulatory bodies.
MedTech & Pharma R&D Pack Setup
To get started with this bundle, install the core pack and its recommended dependencies using the CLI:
npx clawhub@latest install firm-medtech-pack
# Recommended companion skills for clinical and research data
npx clawhub@latest install academic-research
npx clawhub@latest install pdf-documents
npx clawhub@latest install arc-security-audit
Ensure your environment configuration is updated to handle PHI (Protected Health Information) securely by setting SECURE_PRODUCTION_MODE=true and enabling the audit trail via AUDIT_ENABLED=true.
MedTech & Pharma R&D Pack Data Schema & Taxonomy
| Category | Data Managed | Primary Output Format |
|---|---|---|
| Regulatory | FDA 510(k), PMA, CE Marking | Structured Document |
| Clinical | PubMed Metadata, ADMET stats | Research Report |
| Compliance | ISO 13485 & IEC 62304 Audit Logs | 21 CFR Part 11 Audit Trail |
| Legal | HIPAA/MDR Triage Matrix | Anonymized Markdown |
| Operations | Design History File (DHF) | Versioned Technical File |
MedTech & Pharma R&D Pack Advanced Features
- Multi-agent orchestration allows for automated cross-departmental verification of clinical documents and safety reports.
- Enforced anonymization policies using POLICY_BLOCKED_TOOLS to prevent PHI leakage during data exports.
- Integrated 21 CFR Part 11 compliant audit trails specifically designed for high-stakes regulatory environments.
- Automated predicate device comparison for fast-tracking 510(k) submissions using the advanced analytical capabilities of Openclaw Skills.
- Custom sandbox modes for non-main agent workflows to ensure data isolation during R&D prototyping.
SKILL.md
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