Why Resubmit When You Can Ship? How to Accelerate Innovation with PCCPs and CI/CD
Predetermined Change Control Plans (PCCPs) are quickly becoming a critical tool for medical device teams, enabling manufacturers to pre-authorize defined changes, reduce repeated regulatory submissions, and shorten release cycles instead of waiting months for approval. For teams building AI/ML-enabled devices, the impact is even greater, providing a structured path to update models, retrain algorithms, and deploy improvements at the pace of innovation while maintaining regulatory confidence.
If your team is still waiting months to release updates, it’s time to rethink your approach. This session will show how PCCPs, combined with CI/CD, enable you to accelerate product innovation by pre-authorizing changes, automating validation, and releasing updates continuously without sacrificing safety or compliance.
What you'll learn
- How to define PCCPs that pre-authorize changes and accelerate compliant releases for software and AI/ML
- Strategies to automate testing, validation, and release workflows by integrating PCCPs with CI/CD
- Ways to operationalize continuous validation with real-world data, model performance tracking, and drift monitoring
- Tips to embed quality into daily development so teams can ship faster without adding compliance overhead
Who should attend
- 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
- Quality and Regulatory leaders exploring how to use Predetermined Change Control Plans (PCCPs) to manage software and AI changes without repeated submissions, while maintaining audit readiness
- AI and Innovation teams looking to adopt CI/CD in regulated environments and accelerate releases without getting slowed down by manual validation, documentation, and change control
