- How can your organization optimally align the fundamental characteristics of Agile with MedTech regulatory constraints
- Why a hybrid development approach can help your gradual transition to Agile
- Specific practices and techniques to ensure the success of your Agile journey
Watch the webinar
This white paper is accompanied by a webinar in which Dr. Birk elaborates on the paper’s topics in detail.
Watch the session’s recording from 4 Mar 2021 below:
White paper: Unlock the Power of Agile
in Regulated Environments
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.