Disrupting Healthcare
Disrupting Healthcare wrote this long article about the challenges with EU MDR and Health Tech Pathways - in English here: Health Tech Pathways and the Bottleneck Upstream of EU MDR - disrupting.healthcare
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Picking the Right Regulatory Consultant for Your MDR Certification
Let's start simple. A regulatory consultant is the person who guides you through getting your medical device approved in Europe. Most companies have never tried to get a product CE marked. Your strengths is in the product innovation, healthcare understanding, business understanding - and very rarely in the regulatory
Picking Your Notified Body: The Decision That Can Wreck Your Whole Timeline
Let's start simple. If you want to sell a medical device in Europe, and it is above level 1 in MDR, (has an intended use, with a real potential risk, if it doesn't work as planned), you need to have it approved by the EU. The
How We Designed Health Tech Pathways
In my last post, I shared why we built Health Tech Pathways. This one is about how we designed it — a look into our engine room. But how did we end up with this design and user experience? It started with the customers We have seen the frustration in the
The Story Behind Health Tech Pathways: A note from the CEO
I'm often asked why we built Health Tech Pathways. So here it is. It started on a dockside In 2018, I gathered the first seven health tech start-ups on a dockside in Copenhagen. That was the beginning of Health Tech Hub Copenhagen. Since then, we have supported