Do you have a regulatory strategy to help your company prepare for the new European Medical Device Regulation (EU MDR)? With the May 2020 deadline right around the corner, a main area of focus for medical device companies will be transitioning to the new European regulation.
Today’s guest is Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research. Isabella joins Jon Speer in this episode to share what listeners need to do to prepare for EU MDR, despite the recently announced two-year delay of EUDAMED.
“To establish any type of equivalency, you have to have a contract in place with those manufacturers that have equivalent devices to yours.” Isabella Schmitt
“You’ll want to do a gap analysis of the data that you need to be compliant...what you currently have...and what’s publicly available.” Isabella Schmitt
“It’s been difficult for people (and companies) to understand what they’re supposed to do moving forward.” Isabella Schmitt
“This seems to be a huge step towards global harmonization. I know there’s a little pain and suffering that we’re all going to have to go through to get there.” Jon Speer
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The Global Medical Device Podcast powered byGreenlight Guruis where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...