Day

January 23, 1998
Witt Biomedical Corp. 1/23/98 Cardiac catherization monitoring system Failure to establish and maintain adequate procedures for changes to a specification, method, process, or procedure, e.g., software installation procedures are being changed without using an approved process pursuant to established procedures;
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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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