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New update from MDSAP Audit Approach – MDSAP-AU-P0002.008
The MDSAP Audit Approach update introduces clearer requirements across technical documentation, design history, risk management, and sterilisation. A summary of what auditors will now expect.
New update from MDSAP Audit Approach, at a glance
Australia got some more detailed requirements regarding Assessment Technical Documentation and Agreements between Sponsors and Manufacturers
Update of Design Output requirements for Technical Documentation and DHF
Auditors shall search for evidence of inclusion of feedback into risk management, both Product and Processes
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 (https://www.fda.gov/media/166672/download)
KEY TAKEAWAY
What the MDSAP Audit Approach Update Changes
The MDSAP Audit Approach update introduces more detailed Australian requirements for assessment technical documentation and agreements between sponsors and manufacturers, updated design output requirements for technical documentation and the Design History File, an expectation that auditors will look for evidence that feedback is included in product and process risk management, and clarified non-conformity grading for sterilisation processes.
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