Hardware Podcasts

#365: Medical Device Reporting: The Do's and Don'ts

Global Medical Device Podcast · 7 May 2024 · 40m · Episode 365

What this episode covers

Lisa Van Ryn, a medical device guru at Greenlight Guru, explains the FDA’s Medical Device Reporting (MDR) requirements, detailing how manufacturers must evaluate complaints to determine reportability under 21 CFR Part 803. She outlines a decision tree for identifying serious injuries and device malfunctions, emphasizing that the reporting clock starts when any company employee becomes aware of an event, not just quality staff. Van Ryn highlights the distinction between 5-day and 30-day reports based on the need for remedial action to prevent public health risks, and warns against the pitfalls of ignoring customer feedback for trend analysis.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, FDA
Tools
e-Submitter

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