Date :
Place : United States, Palo Alto
Contact Person:Ashutos Swain
Description:
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the supply chain and the interfaces to the EN ISO 13485:2016. Both, the ISO standard and the MDR requires for outsourced processes additional activities and be careful with outsourced processes. Those are not only on the classic supplier side. Those are also on the other side of the company in the area of sales and post market activities. The understanding of this changes and how to implement last minute changes until May 2020 is essential to keep your certificates. You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. Your implementation time until May 2020 is short and need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body. The webinar will describe the following vital topics: Introduction, who must apply the new EU MDR 745/2017 requirements Overview about the changes of the EU MDR 745/2017 regarding supplier and outsourced activities. Explaining of each change Smart and fast ways to implement the changes in your quality management system Fast track internal audit to approve the changes Who is responsible for the activities? Which (new) roles in the company required?Deadline for abstracts/proposals : 30th October 2020
Organized By :Complianceonline
Keynote Speakers :
Check the event website for more details.