What impact will the EU MDR changes have on the medical device ecosystem?This live episode of the Global Medical Device Podcast was recorded at the Greenlight Guru True Quality Roadshow in Houston, with host Jon Speer his special guest Evangeline Loh, vice president of regulatory affairs at Emergo Group. Together they discuss key challenges medical device professionals are facing with EU MDR, how to best manage those challenges, and its impact on the medical device ecosystem.
NOTE: This episode was recorded prior to the official postponement of EU MDR. The DoA is now amended by one year, so when referring to the DoA as 26 May 2020 this will now be 26 May 2021.
“We love regulatory and compliance, or we wouldn’t be doing this on a daily basis.”
“We’re all kind of walking this walk. There’s a lot of certainty, but there’s a lot of uncertainty, right now.”
“It’s not just medical device manufacturers, it’s everyone in the entire enterprise.”
“It’s important to monitor and understand what’s happening because it’s ever-evolving and changing.”
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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...