Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices

June 26, 2025, 1:00 pm EST • 60 mins

Recorded on June 26, 2025 • 60 mins

Beacon Biosignals is a pioneer in the FDA’s latest guidance around machine learning and AI in medical devices. In 2024, Beacon Biosignals received two of the FDA’s 44 total Predetermined Change Control Plan (PCCP) authorizations, ensuring both their hardware and software products remain cutting-edge. In this webinar, we’ll unpack how AI/ML is reshaping medical devices and share practical strategies to navigate evolving regulations— including how to use a PCCP to release every two weeks, like Beacon Biosignals.

What you'll learn

• Leveraging AI in medical devices while navigating regulatory complexity
• How PCCPs streamline compliance and enable rapid AI model updates
• Applying agile methods in regulated settings to accelerate your SDLC

Who should attend

Speakers

Jake Stowe

VP, Client Operations
Ketryx

Formerly

Alexander Chan

VP of Analytics and Machine Learning
Beacon Biosignals

Interested?

Register now