In this episode, Rightley McConnell, VP of Operations at Precision Systems, Inc., covers how to maintain quality and speed when developing medical device software.
Rightley and Dan discuss:
- Challenges to device software development for complex systems
- Use of AGILE methodology in a regulated environment
- Applicable standards including 21 CFR 820, ISO 13485, ISO 14971
- How quality can remain central at each development phase
And more.
Rightley can be reached at [email protected].