Agent skill · product strategy · alirezarezvani
regulatory-affairs-head
Use for medical device market access strategy: FDA 510(k), De Novo or PMA packages, CE marking under MDR, pre-sub meetings, agency deficiency responses or multi-market plans. Analyzes pathways with regulatory_pathway_analyzer.py and tracks submissions with regulatory_tracker.py.
Why this skill is useful
Provides a detailed regulatory strategy framework and templates for FDA and EU submissions that the AI wouldn't reliably generate on its own.
What it needs
About 11k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
Head of Regulatory Affairs Regulatory strategy development, submission management, and global market access for medical device organizations. --- Table of Contents Regulatory Strategy Workflow FDA Submission Workflow EU MDR Submission Workflow Global Market Access Workflow Regulatory Intelligence Workflow Decision Frameworks Tools and References --- Regulatory Strategy Workflow Develop regulatory strategy aligned with business objectives and product characteristics. Workflow: New Product Regulatory Strategy 1. Gather product information: Intended use and indications Device classification (risk level) Technology platform Target markets and timeline 2. Identify applicable regulations per target market: FDA (US): 21 CFR Part 820, 510(k)/PMA/De Novo EU: MDR 2017/745, Notified Body requirements Other markets: Health Canada, PMDA, NMPA, TGA 3. Determine optimal regulatory pathway: Compare submission types (510(k) vs De Novo vs PMA) Assess predicate device availability Evaluate clinical evidence requirements 4. Develop regulatory timeline with milestones 5. Estimate resource requirements and budget 6. Identify regulatory risks and mitigation strategies 7. Obtain stakeholder alignment and approval 8. Validation: Strategy document approved; timeline accepted; resources allocated Regulatory Pathway Selection Matrix Factor 510(k) De Novo PMA -------- -------- --------- ----- Predicate Available Yes No N/A Risk Level Low-Moderate Low-Moderate High Clinical Data Usually not required May be required Required Review Time 90 days (MDUFA) 150 days 180 days User Fee ~$22K (2024) ~$135K ~$440K Best For Me-too devices Novel low-risk High-risk, novel Regulatory Strategy Document Template --- FDA Submission Workflow Prepare and submit FDA regulatory applications. Workflow: 510(k) Submission 1. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/regulatory-affairs-head--4997a3