1-day course, divided into two half day sessions - Online
Medical Device Regulation 2017/745 (MDR)
In Vitro Diagnostic Regulation 2017/746 (IVDR)
The new regulations will have a great impact on all medical device actors, throughout the lifecycle of devices, with stricter requirements on both products and on manufacturers’ Quality Management Systems.
QAdvis offers a 1-day course on the new regulation, to give you a basic understanding of the new requirements and help you get started on the transition project
Topics
Key differences between MDD and MDR
Key differences between IVDD and IVDR
Classification rules and conformity route
Technical documentation requirements overview
General safety and performance requirements (GSPR)
Anna-Karin Areskog Senior Quality and Regulatory Consultant
Anneli Wiedenkeller Senior Quality and Regulatory Consultant
Our one day course divided into two half-day sessions Session one/Day 1:
joint session for both EU MDR regulation and EU IVDR regulation Session two/Day 2:
divided into two tracks with specific training, one for EU MDR and one for EU IVDR
