Hardware Podcasts

What are the Opportunities for Improvement (OFI) for Quality?

Global Medical Device Podcast · 23 Feb 2022 · 42m · Episode 247

What this episode covers

Jon Speer, founder of Greenlight Guru, hosts Mike Drues of Vascular Sciences to discuss the definition and implementation of quality in the medical device industry. They argue that regulatory quality is about consistency rather than subjective 'good or bad' outcomes, and that quality management systems should serve as a business philosophy rather than just a compliance checklist. The conversation highlights the disconnect between product design validation and manufacturing process validation, especially in Class 1 and 2 devices.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, ISO 13485, 510(k), PMA

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