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
This space will be used to share updates, ideas, and insights related to digital health innovation and regulatory pathways. Our goal is to provide useful information for teams building health technologies and navigating complex regulatory environments. In the coming weeks, we’ll be publishing articles about product development, regulatory considerations,