The new work item proposal (NWIP) for a standard for “Healthcare Software Systems – Part 1: General requirements” was approved in IEC. 82304-1 62A 839 CDRead More
A proposal for a guidance document on “Applying the Quality System to Medical Device Data Systems” has been submitted to AAMI by the FDA. The work is expected to be done by the AAMI software committee and the AAMI Quality Management committee.Read More
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