MDRC

EU MDR FDA Clinical Evaluation

MDRC is a medical device regulatory and quality consultancy based in Piešťany, Slovakia. Its team supports EU CE marking, MDR gap analysis, technical files, quality audits and FDA 510(k) submissions. Clinical services include clinical evaluation reports, literature searches and post-market surveillance reviews, with clinical specialists involved where needed. The company is led by owner and consultant Jozef Kováč alongside senior quality and regulatory expertise.

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Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago

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

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel