Hardware Podcasts

#444: Scaling Your QMS: What the FDA Really Expects for MedTech Startups

Global Medical Device Podcast · 30 Jan 2026 · 57m · Episode 444

What this episode covers

Mike Drues, president of Vascular Solutions, joins host Etienne Nichols to discuss how MedTech startups should scale their Quality Management Systems (QMS) to meet FDA expectations without over-investing in unnecessary processes. They emphasize that the Quality System Regulation (QSR) and the new QMSR are starting points, not exhaustive checklists, and that companies must use professional judgment to tailor their systems. Drues advocates for a 'triage' approach, prioritizing Design Controls and Risk Management during early development while deferring post-market systems like complaint handling until the product is closer to launch. The conversation also covers the strategic timing of FDA establishment registration and the dangers of using boilerplate, copy-and-paste quality manuals.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Solutions, Boston Scientific, Medtronic
Products
Ultra Light
Also
ISO 13485, FDA

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