Day

March 3, 1997
Sunquest Information Systems 3/3/97 Blood Bank Software manufacturer 1. Failure to implement and verify solutions to quality assurance problems [21 CFR 820.20(a)(3)]. For example, our investigation disclosed that representatives of your quality assurance program made recommendations to correct software defects which were not been implemented in a timely manner. Specifically, our investigation determined that some...
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Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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