Dr. Oliver Eidel, OpenRegulatory
Agile Development of Medical Devices
Currently, regulatory-compliant software development causes major headaches. Initially, software is developed and code is written. But then, everyone goes crazy, because now they have to create documentation! This sounds a lot like waterfall development, but it's actually much, much worse.
Other fields have made much progress when it comes to management of software projects. You know, all that agile stuff. But can software as a medical device be developed in an agile way? And if so, how would an implementation look like? I'll talk about lessons learned from my consulting experience and which tools to use.
Oliver is a Medical Doctor, Software Developer and Regulatory Consultant. He founded OpenRegulatory (the website you're staring at) after consulting Healthcare companies and seeing that the field is full of good intentions with bad implementations. Prior to founding OpenRegulatory, he worked at Vara where he was part of the team which developed Germany's first AI software and got it certified as a Medical Device.