regulatory-affairs-head

What This Skill Does

The Regulatory Affairs Head skill serves as a high-level digital consultant for medical device companies, specializing in global market access. It provides expert guidance on complex regulatory frameworks including FDA (US), EU MDR 2017/745, Health Canada, PMDA, and NMPA. The skill analyzes product classifications, selects the most efficient regulatory pathways (e.g., 510(k), De Novo, or PMA), drafts technical documentation, and assists in the professional response to agency deficiency letters. It translates dense regulatory requirements into actionable project timelines, risk assessments, and compliance strategies for Software as a Medical Device (SaMD) and physical medical hardware.

Installation

To integrate this skill into your environment, run the following command in your terminal: clawhub install openclaw/skills/skills/alirezarezvani/regulatory-affairs-head

Use Cases

• Pre-submission Planning: Determine if a novel AI algorithm requires a De Novo submission or a PMA.
• Documentation Support: Draft clinical evaluation reports (CER) that satisfy EU MDR 2017/745 requirements for Notified Bodies.
• Deficiency Management: Input FDA/Notified Body query text to receive a compliant, professional draft response.
• Market Strategy: Evaluate the fiscal and temporal feasibility of entering the Japanese market (PMDA) versus the North American market.
• Compliance Audits: Assess existing technical files for readiness against ISO 13485 and FDA 21 CFR Part 820 standards.

Example Prompts

1. "Analyze my AI-based cardiac monitoring device. Given it uses a novel machine learning algorithm, should I pursue a De Novo pathway or is there a valid predicate for a 510(k)?"
2. "Draft a response to the FDA deficiency letter I received regarding my 510(k) submission. The FDA claims our clinical data lacks sufficient diversity in patient demographics. How should we address this?"
3. "Create a regulatory roadmap for launching a Class IIa medical device in both the EU and the US, highlighting key milestones for CE marking and FDA clearance."

Tips & Limitations

This skill is an expert assistant, not a legal counsel. While it excels at structuring strategies and drafting documents, all regulatory submissions must be reviewed by human quality assurance and regulatory affairs professionals. Ensure that your input data is accurate, as specific device details drastically change classification outcomes. Always verify the latest MDUFA guidance documents directly from the FDA website, as fees and timelines fluctuate annually.