ARQon

EU MDR IVDR FDA Clinical Evaluation

ARQon is a Singapore-based regulatory consultancy working with medical-device and healthcare companies. It supports product development, registration and market access across Asia as well as EU and US pathways. Its device services include EU MDR and IVDR quality-system work, FDA-related compliance, global regulatory strategy, technical files, clinical evaluation reports, audits and training.

Learn more

8:09

ChatGPT For Medical Device Documentation (MDR / FDA)?

Dr. Oliver Eidel

785 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

Uncategorized

Authorised Representative For Non-EU Manufacturers

Updated about 1 year ago

Sebastian Skorka