Agile Development of Applications as a Medical Device in a small Enterprise

MASTER Assignment

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

Type : Master M-BIT

Period: Jan, 2021 - Aug, 2021

Student : Veen, R. van der (Remco, Student M-BIT)

Date Final project: Aug 18, 2021

Thesis

Supervisors:

dr.ir. J.M. Moonen (Hans) Assistant Professor (parttime)

+31534891578

 hans.moonen@utwente.nl

Building: Ravelijn

Personal page

dr. M. Daneva (Maya) Associate Professor

+31534892889

 m.daneva@utwente.nl

Building: Zilverling 2029

Personal page

Abstract:

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.