EU MDR – Medical Alley Association

EU MDR

New Medtech Survey Reveals Urgency to Harmonize Regulatory Processes and Streamline Submissions

Medtech accelerating regulatory transformation to ensure global compliancewith changing regulatory requirements PLEASANTON, CA — Dec. 8, 2021 — Modernizing regulatory operations is a top priority for medtech companies to accelerate submissions and reduce market entry barriers, according to the MedTech 2021 Regulatory Benchmark Report conducted by Veeva MedTech. The new research shows that more than half of medtech organizations […]

RQM+ MDR Clinical Evaluation Roadmap: An Interview with Jai Kutty

The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former notified body leaders who understand what reviewers are looking for when evaluating clinical evidence. Introduction to Dr. […]

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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