SHS Webinar „So You Accidentally Built a Medical Device“

Many digital health startups set out to build software - and suddenly find themselves classified as a medical device.

What follows is often confusion: unclear development requirements, unexpected clinical evidence needs.

This webinar helps founders understand what it really means to be a medical device - and how to navigate software development, clinical evaluation, and study design without losing time, focus, or credibility.

In this webinar, we'll start where most founders start: with Agile, the mindset of speed, experimentation, iteration, and customer feedback. We'll then examine what makes software a medical device and why the agile approach breaks down in this case, and what patient safety demands. We'll look at how software causes harm and how risk management frameworks are designed to prevent it. We'll unpack what clinical evidence means for software products and how development outputs translate into regulatory claims. Finally, we'll discuss honest strategies for startups caught between the speed the market expects and the rigor regulators require.