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

July 16, 2024, 1:00 pm EST
Duration: 60 mins
Recorded on July 16, 2024

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

Who should attend

Speakers

Erez Kaminski

Founder & CEO
Ketryx

Clips from this Webinar

• Understanding PCCP in a CICD Environment
• Overview of Predetermined Change Control Plans (PCCP)
• IEC 62304 and Software Lifecycle Management
• Challenges in AI Software Development
• Metrics and Validation in PCCP
• Steps to Validate AI Systems
• Model Validation and Acceptance Criteria
• Integrating PCCP and CICD at Scale
• Designing Systems for Regulatory Compliance
• Challenges in Implementing PCCP
• Ensuring Traceability and Risk Management
• Understanding Product Architecture
• Project Milestones Overview
• Exploring System Traceability
• Reviewing System Architecture
• Finalizing the Release Approval
• Risk Management Insights
• Strategies for Rapid Change
• AI Program Governance Framework
• Closing Remarks and Invitation for Engagement