EU MDR – Medical Alley Association

EU MDR

5 Critical Areas for MedTech to Focus to Ensure Safety, Compliance, & Speed to Market

If 2020 taught us anything, it was that challenges bring innovation. We experienced resilience  as MedTech companies changed how they operate and began leveraging digital ways of working to accelerate the development and delivery of medical devices and diagnostics, while ensuring patient safety. These innovations have given way to long-lasting opportunities for medtech companies to […]

Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs): What the Changes Could Mean for Your Products

This is the seventh in a series of blogs related to some of the key challenges being encountered to the recent updates to EU MDR. The New EU MDR Guidelines The new EU MDR guidelines will involve a lengthy EU MDR checklist including an array of topics, ranging from general administrative information to verification and validation, amongst […]

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