en.co.tec Schmid KG

EU MDR IVDR FDA Clinical Evaluation

en.co.tec Schmid KG is a Vienna medical device and IVD consultancy. It supports regulatory strategy, classification, quality processes, technical documentation and notified body preparation under the EU MDR and IVDR. Its services also cover FDA 510(k) pathways and detailed reviews of clinical evaluation, risk management, GSPR and UDI sections. The company works with startups and established manufacturers from early product questions through market authorization.

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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

12:18

Vigilance For EU MDR and ISO 13485 Compliance

Dr. Oliver Eidel

16 views · 9 months ago

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel