Make Sure Your Organization is Ready for EU MDR Compliance With These Reports.

Is your organization ready for the transition? Have you taken the necessary steps in preparation?  

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At a Glance

Take an in-depth look at the new EU Medical Device Regulation (MDR) where global medical device leaders explored the nuances of the new requirements and answered the industry’s most challenging questions.

These reports cover the implementation of the regulations into national legislation, what the new regulations mean for substance-based medical devices, how to incorporate clinical evaluation requirements into the design and development process, challenges in clinical evaluation for the EU versus China, contractual and QMS-driven implementation of shared economic operator resources, IVDR challenges, UDI and labeling compliance, postmarket surveillance, postmarket clinical follow-up and the consequences of a no-Brexit deal and fewer notified bodies.

Publication and Reports you Will Receive

RF Special Report - EU MDR 

RAPS/KMPG | The race to EU MDR Compliance (Parts 1 + 2)

Key areas covered

Where companies of different sizes and types fall when it comes to the issues detailed in this paper by assessing the challenges they face.

Recommendations for immediate actions by diving into what to do now.

Provides insights into how these changes are likely to play out in the long run.

41% of medical device companies surveyed

stated that they have yet to evaluate the long-term maintenance needed to comply with European Union Medical Device Regulation

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41% of medical device companies surveyed

stated that they have yet to evaluate the long-term maintenance needed to comply with European Union Medical Device Regulation

Is your organization ready for the transition? Have you taken the necessary steps in preparation?  

Make Sure Your Organization is Ready for EU MDR Compliance With These Reports.

Copyright © 2020 Regulatory Affairs Professionals Society. All rights reserved.

Copyright © 2020 Regulatory Affairs Professionals Society. All rights reserved.