ASQ: EU Medical Device Regulations
December 10 @ 8:00 am - 12:00 pm
The train IS coming this time…don’t be tied to the track, be the hero.
Last year the date of application (end of transition) of the EU Medical Device Regulation (EU MDR) was extended as the COVID pandemic gripped the world. It appears that this time around there will be no further extensions and if you haven’t finished your transition work, you are probably in a panic to get this done and may not know where to start.
Alongside this is the continued transition for the in vitro diagnostic manufacturers from the IVDD to the IVDR. This transition is unlikely to be moved and is a much bigger transition than the EU MDR.
This half day virtual workshop will focus your attention on the critical aspects of your quality management system that are needed to support compliance with the European Regulations (EU MDR/IVDR) with examples provided to help understand the actions to be taken. The core information covered will be:
• Post market surveillance reports (PMSR & PSUR)
• Clinical Evaluation/Performance Evaluation Reports (CER/PER)
• Roles of economic operators (additional responsibilities of your authorized representative and others)
• Role of the Person Responsible for Regulatory Compliance (PRRC) within your organization
• Technical Documentation
• Required coordination with your Notified Body
• Other Quality Management System (QMS) requirements
Cost: $50 for ASQ members. $60 for non-members
Registration link: https://my.asq.org/communities/events/item/317/60/2433
Registration closes Monday, December 7, 2020 @ 5pm