punktum

EU MDR

punktum is a Berlin product-development and digital-health consultancy that offers EU MDR support for software and device teams. Its regulatory service focuses on determining MDR applicability, defining device risk classification, identifying documentation and process gaps, and planning a path toward certification. The consultancy combines this regulatory planning with product, design and engineering capabilities for digital health projects.

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Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel

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

As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?

Anonymous

about 2 years ago

We want to bring MDR class I software as a medical device to market. We’ve talked to other founders and checked out the list of MDR class I devices on this website and it seems that MDR class I softwa

Accepted 1 answer

Yes, probably. Long AnswerSome quick background information first! (By the way, if you're interested in a summary of MDR class I in general, check ou