Isotop

EU MDR IVDR FDA

Isotop is a France-based regulatory and quality consultancy led by principal consultant Alizée Mareczko. It works with startups, small manufacturers and other organisations developing or certifying medical devices and technical products. Its regulatory services cover the EU MDR, IVDR and FDA frameworks, while its quality work includes ISO 13485 implementation, audits, training and support for product industrialisation.

Learn more

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

14:05

EU MDR Post-Market Surveillance, Part 2 (+ ISO 13485)

Dr. Oliver Eidel

19 views · 9 months ago