Medical device/medtech regulatory updates this week: The MDSAP Audit Approach (MDSAP AU P0002.010)
A few suggested next steps if you’re impacted here:
1/ Audit your audit program. Your internal audit procedures and checklists likely reference QSR language and clause numbers. Update them to reflect process-based assessment criteria consistent with the revised audit approach.
2/ For AI-enabled devices, SaMD, or anything covered by a predetermined change control plan, your change control SOP needs to explicitly address PCCP boundaries. Auditors will verify that implemented changes stayed within what FDA agreed to in the 510(k) or PMA.
3/ Scrub any controlled documents for outdated references. Search for URPTG (now PRAC), RDC nº 36/2015 (now 830/2023), and RDC nº 40/2015 (now 751/2022). Issue change orders to bring everything current.