NorMed Consulting

EU MDR IVDR FDA Clinical Evaluation

NorMed Consulting is a Copenhagen-based consultancy specialising in medical device software, software as a medical device and AI-enabled products. It supports regulatory strategy and submissions under EU MDR, IVDR and FDA requirements, as well as quality systems, design controls and technical documentation. Clinical services include clinical strategy, literature review, clinical evaluation reports, post-market clinical follow-up and investigation support.

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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