For MedTech startups, navigating compliance can be overwhelming without guidance on where to begin. Former FDA inspector Vincent F. Cafiso breaks down FDA compliance for MedTech startups — from early R&D through regulatory submission and into commercial distribution. Whether you’re preparing your first 510(k), De Novo, or EU transition strategy, this episode gives you the insider perspective on how regulators evaluate your device and quality system.
In this episode, we cover:
- How the FDA evaluates medical devices at different stages of development
- Common regulatory pitfalls that can lead to submission delays or audit findings
- The role of regulatory strategy and early FDA engagement
- Key considerations for Design Verification & Validation (DV&V)
- What you need to think about as you prepare for commercial distribution
Whether you’re building a compliant QMS, preparing for submission, or planning for commercialization, this episode offers actionable insights to help you avoid costly mistakes and stay inspection‑ready. venture.
