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Posts tagged as “SaMD”

US FDA Final and update guidances – Software

Final and update guidances – Software … the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the…

EU MDR Classification Rule 11 – what???

There’s a bit of discussion in Elsmar about EU MDR Classification Rule 11. – Please explain MDR Rule 11 to me. Please feel free to…