Listen in as industry professionals share their thoughts and opinions in this recording from my last Interactive Q&A. Our theme this month was Postmarket Surveillance Requirements for Medical Devices.

3:25 - Overview of Postmarket Surveillance Requirements in ISO 14971:2019
11:15 - Coding customer complaints to identify new harms
13:50 - Different coding systems - MedDRA, FDA Codes, IMDRF codes
20:15 - Using MedDRA codes - industry best practices
26:00 - Standardizing harm codes using MedDRA
32:00 - Handling disagreements in assigning Severity levels and probability of harms
41:55 - Can we use postmarket data for the validation/re-validation of reusable medical devices?

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