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
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
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
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
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
Leading Danish start-up media, "Bootstrapping", published this article around the launch of Health Tech Pathways. In Danish - 32 mio. kr. til Jesper Grønbæk & HTHC skal katapultere health-startups gennem regulatorisk jungle
Leading Danish Medtech media - "Medwatch", published this article around the launch of Health Tech Pathways. In Danish - Novo-midler fra 2024 får ben at gå på: Healthtech-hub lancerer AI-platform hurtigere godkendelser
Why starting the regulatory conversation early is the smartest decision a health tech founder can make. Health tech founders think about risk constantly. Market risk, technical risk, funding risk. There is one that almost never makes the list. And it is the one most likely to stop you. It builds
The Notified Body has not gone silent because your file is bad. It may have gone silent because no one told you what to expect, and no one inside is obligated to update you. That is not a bug in the process. It is the process. Most founders manage this
Most founders think clinical evaluation is a document. It is not. It is a process, and Annex XIV of the MDR defines exactly what that process requires. The founders who treat it as paperwork tend to discover the difference at the wrong moment. You write your evidence strategy around a
Most founders building a medical device spend their first regulatory conversation asking the wrong question. They ask: what do we need to do to get certified? The better question is: what does our product claim to do? That single answer determines every regulatory decision that follows. Your intended purpose is
One sentence on your website can turn your wellness app into a regulated medical device. Not the code. Not the algorithm. The sentence that describes what the product does. Founders pick their framing early. You write the app-store copy. You brief the marketing team. You pitch investors. Each decision