Hardware Podcasts

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Global Medical Device Podcast · 22 Sept 2021 · 27m · Episode 229

What this episode covers

Mark Alpert, Director of Quality at Greenlight Guru, discusses the current state of quality in the medical device industry with host Jon Speer. Alpert argues that complexity in quality systems guarantees mistakes and that companies have lost their way by focusing on compliance rather than continuous improvement. He advocates for a 'do versus don't do' mindset during audits to preserve creativity and simplify processes, noting that the industry is currently struggling with the transition to EU MDR and IVDR regulations.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, TÜV SÜD, Kasota Engineering
Also
Mark Alpert, Jon Speer, ISO 9000, ISO 13485, EU MDR, EU IVDR, Christie Johnson

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