CTO at medical device start-up Scopis. Desktop Software Architect. Medical Device Regulation Ninja. Not afraid of IEC 62304, IEC 60601, IEC 62366, ISO 13485/9001.
I am very confident architect of desktop software, with lots of experience from freelancer projects, leading a team of 10 students to build a 300.000 LOC project and now being in charge of a medical device software in C++/QT. With my PhD in Software Engineering under my belt, I know what I am doing if it comes to snappy responsive UI, achieving concurrency and scalable architecture. I made applications scale to include 50 new features in half a year, where it needed months to add a single one before.
My PhD thesis is on change management in Open Source projects and applies equally to all volunteer organizations and open communities. I have studied over 10,000 conversations regarding changing the infrastructure, management, processes and tools in Open Source projects. I can provide strategies to make change happen, describe patterns to avoid and help you separate feasible ideas from ones which will never work.
As CTO Software at Scopis Medical, me and my partners have successfully declared conformity for a medical device including software within less than 6 months. Building processes is in my blood from my PhD in software engineering. Tackling ISO 13485/9001 and IEC 62304 was thus a breeze. I want to share this expertise to help others avoid spending too much time on device regulation in Europe. Can assist in usability process engineering (IEC 62366) and safety for electric devices containing software (IEC 60601-1 chapter 14).