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.
Register for this webinar to learn how PCCPs enable faster, compliant software and AI/ML updates in regulated medical device environments.
Speakers
Jenn Dixon, Director of AI Quality & Regulatory Strategy, Ketryx
Jenn Dixon leads quality and regulatory client engagements at Ketryx, providing coaching and support to clients wishing to adopt the best Software Medical Device practices. Jenn brings extensive expertise in quality assurance, regulatory affairs and project management from previous roles in the MedTech industry with a proven ability to develop and apply best practices that optimize both teams and processes.
Prior to Ketryx, Jenn was the Director of QA/RA at Omniscient Neurotechnology, overseeing global regulatory submissions, maintaining ISO 13485 compliance and managing cross-functional teams in areas such as post-market surveillance and Good Machine Learning Practices (GMLP). Jenn also served as a Design Assurance Specialist and Technical Project Manager, excelling in risk management, audit readiness and leading agile development teams to deliver innovative solutions.
Jenn began her career at Synaptive Medical, supporting ISO 13485 compliance transitions and leading UDI implementation. She holds a Bachelor’s degree in Engineering from the University of Toronto.
Message Presenter
Adrian Samsel, Director of Client Operations, Ketryx
Adrian Samsel works with large enterprises to accelerate product innovation using AI while maintaining quality and regulatory rigor.
Prior to Ketryx, Adrian held leadership roles at Novanta, including Director of the Program Management Office, where he managed a global portfolio of new product introductions and sustaining initiatives supporting over $200M in annual revenue. He standardized tools and ways of working across divisions while maintaining ISO 9001 and ISO 13485 compliance and drove adoption of the Atlassian ecosystem to reduce manual overhead and accelerate development in complex, regulated environments.
Adrian began his career at Boeing, where he supported the design, testing and certification of flight systems, including defining test requirements and leading safety and failure-mode analyses.
He holds a Master of Science in Product Development Engineering from the University of Southern California and a Bachelor of Science in Mechanical Engineering from the Massachusetts Institute of Technology.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Quality and Regulatory leaders exploring how to use PCCPs to manage software and AI changes without repeated submissions, while maintaining audit readiness
- R&D and Engineering teams looking to adopt CI/CD in regulated environments and accelerate releases without getting slowed down by manual validation, documentation and change control
- AI and Innovation teams building AI/ML-enabled products who want a compliant path to continuously update models using PCCPs and integrate retraining into CI/CD workflows
What You Will Learn
Attendees will learn how to:
- Define PCCPs that pre-authorize changes and accelerate compliant releases for software and AI/ML
- Automate testing, validate and release workflows by integrating PCCPs with CI/CD
- Operationalize continuous validation with real-world data, model performance tracking and drift monitoring
- Embed quality into daily development so teams can ship faster without adding compliance overhead
Xtalks Partner
Ketryx
Ketryx transforms the product lifecycle for life science teams, enabling faster, safer releases. Trusted by three of the top five medical device makers, its AI-native platform overlays existing tools to automate documentation, ensure traceability, and cut manual work by 90%—boosting compliance, quality, and speed without disrupting current workflows. Learn more at ketryx.com.
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