In this webinar, you will learn how the Medical Device Single Audit Program (MDSAP) can be applied under the EU Medical Device Regulation (MDR 2017/745) / In Vitro Diagnostic Regulation (IVDR 2017/746). We will introduce MDSAP and the new MDSAP auditing approach. We will discuss how MDSAP audit reports can be used by Notified Bodies for surveillance audits carried out under the MDR/IVDR, based on the Medical Device Coordination Group Guidance MDCG 2020-14. In addition, we will highlight the similarities and differences between Notifies Bodies and Auditing Organizations with respect to their roles, followed auditing process and approach.
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