EUMEDIQ

EU MDR IVDR Clinical Evaluation Cybersecurity

EUMEDIQ is a medical device regulatory service provider headquartered in Zug, Switzerland, with German and UK offices. It supports manufacturers from initial regulatory strategy through market entry and post-market compliance. Consulting covers device classification, technical documentation, clinical evaluation and post-market surveillance under MDR and IVDR. The firm also offers authorized representation, quality-system auditing, information-security and cybersecurity advice, and support for software-driven medical devices.

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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

15:16

Registering Your UDI in EUDAMED (Medical Device Database)

Dr. Oliver Eidel

1 K views · 8 months ago

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel