Day

October 30, 1998
Allergy Laboratories 8/14/98 8. There are no controls for computer generated labeling used for product inserts. It was noted during the inspection that finished HealthTest HIV 1 + 2 and HBsAg test kits were relabeled from “For in vitro use only” to “For Research Use Only”. SoftwareCPR keywords: software validation, CDRH, devices
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ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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