I3CGlobal

EU MDR IVDR FDA Clinical Evaluation

I3CGlobal is a medical-device regulatory and compliance consultancy founded in India with teams in India, Germany, the UK and the United States. It supports EU MDR and IVDR technical documentation, FDA 510(k) submissions, clinical evaluation and quality-system projects. Its services also include CE marking, QMSR, ISO 13485, authorized representation and post-market documentation.

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Notified body

3EC International

updated 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