The new Medical Device Regulation imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices. While advanced preparation and early action is key to ensuring a smooth transition to the new requirements, medical device manufacturers are expected to encounter challenges pertaining to review and approval processes, among others.
To address these challenges, TÜV SÜD’s experts will share insights on key changes, assessment procedures and other requirements, through our ‘Fit for MDR’ series of complimentary webinars. Know more about out topics and register for the same below:
Part 1 : Biocompatibility
Biocompatibility is the biological evaluation of Medical Devices in compliance with the standard ISO 10993-1: 2018. Through this webinar, our expert will provide a comprehensive understanding on the requirements and key elements pertaining to the biological evaluation of medical devices put forth by ISO 10993-1:2018.
Part 2 : Packaging
The Packaging module under MDR captures a holistic insight on the expectations by the Notified Body, in order to understand the documentation for the usability evaluation of the sterile barrier system.
Part 3 : Sterilization
The Sterilization module under MDR covers a comprehensive discussion about EO residuals, in relation to patient population.
Part 4 : TD Assessment
This module aims to provide a holistic understanding on the Technical Documentation Assessment according to Annex IX Chapter II.