Predetermined Change Control Plans (PCCPs) are quickly becoming a critical tool for medical device teams, enabling manufacturers to pre-authorize predefined changes, reduce repetitive regulatory submissions and shorten release cycles rather than waiting months for approval.
However, medical device teams continue to face long release cycles, manual validation processes and repeated submissions when updating software and AI/ML-enabled products. This webinar examines how PCCPs, combined with continuous integration and continuous delivery (CI/CD), create a structured, compliant framework for pre-authorizing changes, automating validation and accelerating release timelines while maintaining regulatory confidence.
The featured speakers will explore practical approaches for defining PCCPs that support software and AI/ML updates, integrating automated testing and documentation into CI/CD workflows and operationalizing continuous validation through real-world data, model performance monitoring and drift detection. The webinar will also address how to embed quality management principles directly into development processes to reduce compliance burden without compromising safety.
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