Ambit Iberia

EU MDR IVDR FDA Clinical Evaluation

Ambit Iberia is a Barcelona-headquartered consulting firm with medical device regulatory and digital compliance services. It supports product classification, EU MDR and IVDR transitions, ISO 13485 systems, technical documentation, clinical evaluation, CE marking and international market access including FDA pathways. The company also offers ongoing regulatory-affairs support and software tools for quality and documentation management, with offices in Spain and Portugal.

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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

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel

As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?

Anonymous

about 2 years ago

We want to bring MDR class I software as a medical device to market. We’ve talked to other founders and checked out the list of MDR class I devices on this website and it seems that MDR class I softwa

Accepted 1 answer

Yes, probably. Long AnswerSome quick background information first! (By the way, if you're interested in a summary of MDR class I in general, check ou