Accelerating Approvals: Leveraging the FDA’s Product Change Control Plans (PCCPs)
Time: 3:30 pm
day: Day One Track B PM
Details:
- Streamlining product changes by using PCCPs to accelerate approvals for AI-powered medical devices while maintaining compliance with the FDA
- Optimizing change documentation by understanding best practices for creating comprehensive change control plans that align with FDA expectations for medical devices with AI components
- Avoiding approval delays through real-world case studies that demonstrate how leveraging the PCCP process can reduce time-to-market for AI-driven medical devices