Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices

The FDA's Predetermined Change Control Plan (PCCP) allows medical manufacturers to update their device without repeated approvals. With this regulatory strategy, top medical device companies are incorporating agile methodologies into their work, including Continuous Integration and Continuous Delivery (CI/CD), so they can bring products to market faster while still ensuring safety and regulatory compliance.

What you'll learn

To help you start using CI/CD and PCCPs for your AI/ML-enabled products, this webinar will examine:

• Practical and systematic approaches to designing, constructing, and validating a successful PCCP with examples of model creation, data training, bias assessment, testing, and best-in-class infrastructure
• Processes for post-market ML software releases that enable continuous validation in production including ingesting real-world data, modification protocols, and metrics for ML models
• Strategies for implementing CI/CD to fulfill a PCCP for a SaMD project to accelerate product release cycles