Hardware Podcasts

#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

Global Medical Device Podcast · 15 Aug 2024 · 36m · Episode 379

What this episode covers

Vernon Baker, a veteran medical device engineer and quality expert, explains how early-stage MedTech companies can build effective Quality Management Systems (QMS) without massive resources. He emphasizes that early quality hires must be 'jack of all trades' who understand core regulations like ISO 13485 and 21 CFR 820, but prioritize humility and the ability to find answers over being an expert in everything. Key strategies include rigorous supplier management, treating suppliers as extensions of the manufacturing process, and conducting real, risk-based management reviews rather than checkbox exercises. Baker also highlights the importance of establishing a formal regulatory intelligence process to track standards like ISO 14971 and EU MDR, ensuring compliance drives product development and business survival.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Rook Quality System
Also
ISO 13485, ISO 14971, 21 CFR 820, EU MDR, TUV Sud, BSI, Oriel Stata Matrix

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