Hardware Podcasts

Most Common Problems Found During FDA Inspections in 2022

Global Medical Device Podcast · 23 Mar 2023 · 44m · Episode 311

What this episode covers

Mike Drues, President of Vascular Sciences, analyzes the FDA's 2022 inspection data to identify the most common reasons for Form 483s, highlighting CAPA, design controls, and complaint handling as the top three issues. He argues that these problems persist because companies focus on ticking regulatory boxes rather than understanding the underlying intent, often failing to perform adequate root cause analysis or document their quality management systems effectively. Drues emphasizes that medical device professionals must move beyond minimum compliance to prevent recurring errors and ensure patient safety through proactive prevention and rigorous validation.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, ISO 13485, 21 CFR Part 820

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