The development of medical technology is greatly supported by Agile approaches to software and product development. That said, due to regulatory constraints, advanced Agile workflows and practices are required to successfully tackle compliance aspects of development.
In this webinar, Agile and process expert Dr. Andreas Birk shares insights on specific Agile practices (methods, workflows, templates, and more) that help apply the iterative approach in medical device development. Some examples he touches on are using the Definition of Done to manage regulatory requirements, establishing traceability links between artifacts, and building compliance in an incremental way.