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

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

Clips from this Webinar

Speakers

Jake Stowe

VP, Client Operations Ketryx

Alexander Chan

VP of Analytics and Machine Learning Beacon Biosignals