During a recent client interaction a topic of interest came up and I am looking for feedback.
Since 2002, software validations (as required by the FDA for software used in or as a medical device or in its production, including document and record control) has required a thorough, document heavy validation for its intended use. In Feb 2026, new guidance was published that would lower the burden on medical device manufacturers. The Software Assurance (instead of software validation) would only focus on parts of the software that were the source of the highest risk to the patient, product quality or compliance to standards (such as ISO13485).
My question for the community - has anyone implemented the 2026 Computer Software Assurance (https://www.fda.gov/media/188844/download) instead of the 2002 Computer Software Validation (https://www.fda.gov/media/73141/download)? Was the implementation successful? Are there any suggestions?
Thank you for the feedback.
Regards,
Nanda
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Nanda Filkin
QA Scientist
Arete Biosciences
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