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 rmcconnell@psi-software.com.
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