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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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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