Credas

EU MDR IVDR FDA Clinical Evaluation

Credas is a Singapore-based medical-device consulting firm supporting regulatory, quality, clinical and market-access work. Its services cover EU MDR and IVDR dossiers, FDA pathways, quality systems and clinical affairs. The clinical team also prepares clinical evaluations, CEPs and CERs, plans post-market clinical follow-up and supports clinical investigations for medical devices, IVDs and software products.

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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

Uncategorized

Clinical Evaluation

Updated almost 2 years ago

Dr. Oliver Eidel