Posted By
Dan O'Leary
02-May-2024 17:16
Found In
Egroup:
Regulatory Open Forum
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If something happened to an end user and you learned about it, then you will initiate a complaint under 820.198. The complaint triggers an investigation to determine if it is reportable as a Medical Device Report, MDR, under Part 803. From the brief description, I would expect it is reportable. You ...
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