- How the Definition of Done helps address regulatory constraints
- Specific practices to implementing DoD
- Managing nonfunctional & quality requirements in Agile to support regulatory compliance
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 29 Apr 2021 below:
White paper: Agile Best Practices for Medical Device Development
As evidenced by a large number of successful teams & products, Agile can definitely support regulated product development in the life sciences sector. However, ensuring regulatory compliance necessitates the use of certain Agile practices.
In this white paper, Agile process expert and founder of Software.Process.Management Dr. Andreas Birk provides an in-depth overview of the Agile practices that help regulated development. The white paper proposes a way for organizations in medical device development to build an Agile QMS and achieve compliance incrementally in an Agile way.
Download this white paper for practical information on the methods and strategies that help implement Agile successfully in safety-critical product delivery!