CMS SciDoc

EU MDR FDA Clinical Evaluation

CMS SciDoc is a Melbourne-based consultancy helping medical-device companies plan and execute global market-access projects. Its team supports quality systems, product registration, testing coordination and technical writing. Document services include EU MDR technical dossiers, FDA 510(k) submissions, TGA conformity-assessment dossiers, clinical evaluation reports, usability reports and biocompatibility reports.

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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