I'm a doctor by training but worked as a software engineer in medical software startups. Most of my time was spent at Vara Healthcare in Berlin, where we developed Machine Learning - based Radiology software.
We quickly noticed that certifying software as a Medical Device is quite tricky. And it sucks, because knowledge isn't freely available.
I left Vara to build my own business around a self-developed HR software (that didn't go well). Only then did I notice that other Healthtech startups are struggling with their Medical Device certification, too.
I got the opportunity to help other startups certify their software and resolve regulatory pain, most recently Ada Health in Berlin.
Turns out: Getting this done is pretty simple, if you know what you're doing. Unfortunately, there are a lots of consultants who make this unnecessarily complex.
I'm not very interested in regulatory consulting. I am however interested in enabling Healthtech startups access the market.
So I built this website to brain-dump my regulatory knowledge. I hope that this reduces the pain for future startups and finally enables some desperately-needed innovation in our crappy Healthcare IT Systems. Enjoy!