New update from MDSAP Audit Approach – MDSAP-AU-P0002.008

New update from MDSAP Audit Approach, at a glance:

1. Australia got some more detailed requirements regarding Assessment Technical Documentation and Agreements between Sponsors and Manufacturers
2. Update of Design Output requirements for Technical Documentation and DHF
3. Auditors shall search for evidence of inclusion of feedback into risk management, both Product and Processes
4. Clarified equirements for NC grading in sterilization processes

If you intent to implement MDSAP in order to streamline audit efforts globally, reacht out to EUMEDIQ if you need support. We are providing implementation support and mock audits before you get into stage 2 of MDSAP certification.

Link to document