Hardware Podcasts

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

Global Medical Device Podcast · 10 Nov 2021 · 30m · Episode 235

What this episode covers

Tom Rynkiewicz, VP of RA/QA at Raland Compliance Partners, joins host John Spear to discuss the top compliance issues plaguing medical device manufacturers, specifically CAPA, complaints, and design controls. Rynkiewicz argues that these recurring FDA observations stem from flawed internal audit practices that audit isolated quality system components rather than the entire system holistically. He highlights how human behavior and corporate KPIs, such as tracking CAPA turnaround times instead of effectiveness, prevent companies from achieving a true quality culture with zero complaints. The conversation emphasizes the need for system-level auditing and transparency to prepare for potential FDA shifts toward stricter Good Manufacturing Practices (GMP) inspections.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Raland Compliance Partners, Abbott Labs
Also
FDA, ISO 13485, Patrick Lencioni

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