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Join ELPRO Validation/Qualification Expert Sean Merrill for a discussion about the new EU Medical Devices Regulations going into effect May 2020.
Why the change? Novel technology, such as software-enabled devices, has led to a tighter review of safety. Recently there has been a significant number of high-risk device failures and recalls.
The new regulation chapters include use of microplate washers, dura guard devices for craniotome, heart bypass cannulae devices, and most considered for safety reasons are combination devices. So where does that leave your product? Discuss with us how the new regulations affect your products and supply chain practices.
As a supply chain and QA professional, you will learn:
Where your product fits now in the scope of the new MDR
Which class and what the requirements are for that class
Requirements for Unique Device Identifier (UDI)
Concerns about increasing post-market surveillance