I'm Oliver, a medical doctor by training. I did my doctorate research in Neuroradiology and published a few papers there. That's how I got into developing software which is the most fun activity for me, ever. I worked at Vara, a Berlin-based company developing machine learning - based breast cancer screening software. There, I developed the first version of the software, built the software team, got the medical device certification (MDD Class IIb) and built the regulatory team.
Now, I've founded my own company called OpenRegulatory. We noticed that other regulatory consultants don't do a good job - not because they're evil by nature, but often because they don't understand software well or are simply disorganized. We try to be different: We value transparency, efficiency and modern tooling. That's why we publish all our templates for free, host a free Slack community for 800+ people to get answers to their regulatory questions, and we offer a eQMS software called Formwork with over 1.100 companies signed up already.
Our end goal is to make consultants unemployed, including us. I like to think about this like when you try to learn software development: There are so many free resources out there and you don't need a "software development consultants" to teach you how to develop software. You teach yourself. And, one day, we hopefully have enough regulatory resources on our website so that you can teach yourself and only need our help when dealing with complicated questions. Long-term, regulatory software like Formwork will have the most leverage in increasing your efficiency.
We also like the idea that, by helping many startups enter the market who wouldn't have made it with other consultants, we can increase the diversity of Healthcare software and thereby help bring some innovation to hospitals which are full of crappy software.