Hardware Podcasts

#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech

Global Medical Device Podcast · 23 Jun 2025 · 16m · Episode 412

What this episode covers

Ashkon Rasooli, speaking at the LSI conference, outlines a phased approach to building a Quality Management System (QMS) for medical device startups, arguing that compliance should be integrated early to avoid being burdensome. He introduces a 'Phase 0–6' model, advising founders to build a quality culture during the feasibility phase rather than implementing formal controls too early. Rasooli emphasizes anticipating 'enforcement points' from regulators like the FDA or investors, rather than reacting to them at product launch, to ensure smoother design transfer and post-market surveillance.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, ISO 13485, ISO 9001, ISO 14155

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