MDS Finland

EU MDR Clinical Evaluation FDA

MDS Finland is a specialist consultancy established in 2015 to serve medical device manufacturers, distributors and importers. It provides quality management, regulatory affairs, technical documentation, clinical research and commercialisation support. Services include CE technical files, clinical evaluation reports under EU MDR, biological evaluation, FDA approval processes, PRRC support and quality-system auditing, covering the product lifecycle from planning to post-market.

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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