Free Webinar | MDR Auditing with an MDSAP Model

July 07, 2021

Date: July 7th, 2021

Time: 09.00 - 10.30 CET

Location: Virtual

Language: English


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.


Henk-Willem Mutsaers
René Schings
Post date: May 21, 2021
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