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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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