Webinar

On-Demand Webinar | MDR Auditing with an MDSAP Model

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).

You'll be introduced to 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.



Download & view
Henk-Willem Mutsaers
René Schings
Post date: July 06, 2021
Tags
How can we help you? Contact us