Panabistics

FDA EU MDR

Panabistics is a Kitchener-Waterloo, Ontario MedTech consultancy supporting medical device market access and compliance. Its FDA work includes pathway strategy, 510(k) and eSTAR submission support, De Novo and PMA guidance, and mock deficiency reviews. The firm also supports EU MDR technical-file readiness, Health Canada licensing, SaMD and AI-enabled device classification, quality-system implementation and post-market compliance.

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Free MDR Templates

Dr. Oliver Eidel

103 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

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel