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Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
Date :
Place : United States, San Jose
Contact Person:Ashutos Swain
Description:
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union. 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 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 “Post Market Surveillance Activities” and the frequently reporting to the Notified Bodies and the Authorities. Attend this webinar to keep yourself up to date. Learn how to understand the requirements and how to create the reports. Introduction, who must apply the new EU MDR 745/2017 requirements Overview about the changes of the EU MDR 745/2017 regarding the “Post Market Surveillance” - 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? Responsibilities for “Post Market Surveillance” - activities What reports are required? What is the input for the reports? How to create the reports? How often the reports required? Adjustments in the management review How to work with the output of the reports in the quality management system processes and the technical documentation? We are manufacturer of implantable diaphragm pacemaker and we only sell low volume. Can we use number of patients when doing PMS rather than number of devices sold? For example we sold 30 for the year. we received a 2 complaints. Do we calculate the 2 complaints based on the devices sold or can we use number of active patients? complaint linked to use of the device? For Post-market clinical follow-up if I understood correctly it is NB that will send to EUDAMED but not clear for ICSR reports for 15 day reports. For vigilance reporting for 15 day - will manufacturer be required to report directly to EUDAMED? What about if the complaint was due to user error? Do you need to include this to the PMS as a complaint? Package damage can be from delivery person/agency also, so are we responsible to note?Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017 will be held in San Jose,United States on date 2020-12-14
Deadline for abstracts/proposals : 4th December 2020
Organized By :Complianceonline
Keynote Speakers :
Check the event website for more details.
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