November 14, 1996
WARN 11/14/96 Digisonics 1. Failure to establish and implement adequate quality assurance procedures that provide detailed descriptions of the procedures to be used to perform regression testing after changes to the software have occurred [21 CFR 820.100(a)(2)]. We acknowledge your response to the FDA-483 dated July 10, 1996. The information in your response is inadequate...
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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.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.