Case Study

6 essential steps to ensure MDR compliance before May 2021

6 essential steps to ensure MDR compliance before May 2021

Pages 18 Pages

6 essential steps to ensure MDR compliance before May 2021 Author: Matthias Havenaar WHITEPAPER JULY 2020 Is your company ready for May 26, 2021? Although delayed by one year in response to the COVID-19 pandemic, the time to act is now. This white paper provides 6 practical steps that every medical device company needs to take to ensure MDR compliance. castoredc.com 2 Content Introduction Is your company MDR-Ready? How did we get to MDR from MDD? 6 most important differences between the MDD and the MDR Step 1: Which devices will stay or go? Start with a gap analysis Be realistic...and ruthless Step 2: Do you have the right clinical data? Remediate the gaps in your clinical data Anticipate gaps for legacy devices Step 3: Are you talking to the right notified body? Prepare for

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