Hardware Podcasts

Understanding and Handling Different Types of Feedback

Global Medical Device Podcast · 14 Jan 2021 · 34m · Episode 175

What this episode covers

Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research, explains the regulatory distinctions between product feedback, complaints, and adverse events for medical device companies. She details the criteria for classifying complaints under 21 CFR 820, the strict timelines for filing Medical Device Reports (MDRs) with the FDA for deaths or serious injuries, and the importance of proactive monitoring via databases like MAUDE. Schmitt emphasizes that all staff must be trained to capture feedback to ensure qualified personnel can determine if an event requires investigation or root cause analysis.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima Clinical Research, Green Light Guru
Also
FDA, MAUDE, 21 CFR 820, ISO 13485

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