MDR Consulting Group

EU MDR IVDR

MDR Consulting Group M. IKE is a Greek scientific and technical consultancy established in 2023 to continue the medical device work of ANPLUS Engineering. Its team prepares technical documentation under the EU MDR and IVDR, supports CE marking across higher-risk device classes, coordinates testing and notified body work, and can provide PRRC support. The practice also develops management systems and advises on EUDAMED obligations.

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3:06

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

12:18

Vigilance For EU MDR and ISO 13485 Compliance

Dr. Oliver Eidel

16 views · 9 months ago