Hardware Podcasts

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

Global Medical Device Podcast · 14 Jun 2021 · 34m · Episode 213

What this episode covers

Jon Speer, founder of Greenlight Guru, interviews Mike Drues, president of Vascular Sciences, about the FDA's FY2020 inspection data for medical device quality systems. They analyze the top three most cited 483 observations: CAPA, complaints, and design controls, noting that these accounted for approximately 35% of all findings. Drues and Speer discuss the critical failure of manufacturers to document procedures, investigate complaints, and use production-equivalent devices for validation, emphasizing that these are basic regulatory requirements rather than complex nuances.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, 21 CFR Part 820

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