Agile development of applications as a medical device in a small enterprise

For micro- and small-sized enterprises developing software in the medical device industry, it is challenging to comply to regulations and standards. This research proposes a method to simplify documentation, tool usage and development lifecycle for micro- and small-sized enterprises, by keeping overhead to a minimum while still complying to regulations and standards. We do this by adapting an agile method tailored to the safety-critical industry, called SafeScrum. The method is operationalized and implemented into a micro-sized enterprise using Action Design Research, after which adjustments are made. We conclude that the method provides promising results for micro-sized enterprises wanting to develop software in lower risk classes. More evidence is necessary to give conclusive results.