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EU-medical device 2020 - EU-medical device regulation and in vitro diagnostics regulation compliance



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Topics/Call fo Papers

Recently, the European Union has revised the regulatory requirements governing medical devices; including the establishment of new expectations and approaches to post-market surveillance. Mandatory compliance to the new European Medical Device Regulation (MDR) is set for 26 May 2020.
Due to the regulation changes, medical device manufactures are focused on implementing quality systems to maintain GMP compliance. In order to achieve that goal, it is essential that medical device manufacturers understand and correctly implement the requirements for post-market surveillance.
Module 2
Review the new EU-MDR 2017/745
Key compliance dates
Transition from Re-active to Pro-active
Data Inputs and Collection Methods
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Last modified: 2020-10-14 18:42:02