Hands on Research

EU MDR Clinical Evaluation

Hands on Research is a medical device regulatory consultancy based in Liverpool, United Kingdom. Its work concentrates on EU MDR compliance and the clinical evidence needed to demonstrate device safety and performance. Services include clinical evaluation reports, post-market clinical follow-up, periodic safety update reports, summaries of safety and clinical performance, post-market surveillance planning, biocompatibility, claims review and risk management.

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Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago

Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software