Despite the naturally existing tension between Agile and regulatory compliance constraints, MedTech development has a lot to gain from Agile methods. Yet due to its origins, Agile isn’t always optimally prepared to deal with regulatory requirements and the needs of combined hardware/software systems development. Special attention is required to adapt Agile strategies to the needs of regulated medical device development.
In this white paper, renowned process expert and founder of Software.Process.Management Dr. Andreas Birk lays out a gradual path for life sciences product development organizations to unlock the power of Agile.
Download this white paper to understand how the basic principles of Agile may be aligned with regulatory constraints, and what Agile methods you can rely on to support your transition. The white paper also touches on Agile practices including QMS, establishing your Definition of Done, and Agile testing strategies to support built-in quality and compliance.