Since the result of the SaMD manufacturing process is the software which is subjected to software verification and validation, then it generally holds true that manufacturing process validation (i.e., per ISO 13485 clause 7.5.6, U.S. FDA 21 CFR 820.75, etc.) is not applicable. Consider a policy-level statement in the non-application narrative of your Quality Manual.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 29-Apr-2022 04:06
From: Malin Kylberg
Subject: Process validitation for SaMD
For a medical device being a soft ware I don´t think that process validation really apply.
Do yuo think that we need to have process validation any way described in a SOP in our QMS?
Thanks in advance!
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Malin Kylberg
Mallyk QA Consulting
Uppsala
Sweden
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