March 7, 1997
Separation Technology 3/7/97 Centrifuges 4. Failure to document, review, approve, and validate changes to components, finished devices, labeling, packaging or manufacturing process specifications [21 CFR 820.100(b)(1),(2) & (3)], e.g., there is no documentation of the prior approval of the software specification change initiated 1/24/97 that was an attempt to correct the failures described above. Also,...
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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.

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