AAMI Book SW Validation Chapter Reprint

A reprint of the Software Validation Chapter of the 1997 AAMI book “Current Issues in Medical Device Quality Systems” is at the link provided.

This chapter was authored by Alan Kusinitz, Managing Partner of SoftwareCPR. Although not entirely up to date it is still useful reading for those involved in software validation for Medical Devices or production and quality system software.

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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