Understanding PCCP for AI/ML Medical Devices: Webinar

Randy Horton

Published on: February 6th, 2025

Stay ahead of the curve in the rapidly evolving world of AI/ML medical devices! Join Orthogonal and leading industry experts for a webinar that unveils the power of Predetermined Change Control Plans (PCCP) in revolutionizing FDA submissions and product updates. As we navigate the complex regulatory landscape, we’ll be paying close attention to industry regulatory updates to ensure you have the most current information.

What You’ll Learn:

PCCP essentials: Simplifying AI/ML medical device regulatory submissions
Using PCCP with AI/ML: Leveraging PCCP for AI/ML device updates without full resubmission
Real-world applications: Explore successful examples of PCCP implementations in medical devices
Regulatory landscape: Latest FDA guidelines for AI/ML software updates

Why Attend?

Whether you’re in regulatory affairs, digital health, or medical device development, you’ll learn how to leverage PCCP to reduce submission times, reduce costs and bring your devices to market faster.

Don’t let regulatory complexities slow down your AI/ML medical device innovations. Join us to gain practical insights and real-world strategies for confidently navigating the evolving regulatory landscape.

Save Your Spot

Speakers

Brendan O’Leary, Digital Health Technology Consultant
Brendan O’Leary provides consulting services on digital health and medical device regulatory strategy to technology developers, healthcare organizations, trade and professional associations, and other stakeholders.
Brendan worked at the FDA for 14 years in a variety of roles, most recently as the founding Deputy Director of the Digital Health Center of Excellence and as its Acting Director throughout 2022. Brendan contributed to hundreds of precedent-setting decisions and co-authored dozens of policy documents that continue to provide the foundation for the FDA’s digital health efforts. He frequently represented the FDA on digital health and other topics through presentations at conferences and professional society meetings, press interviews, and interactions with Congress. Brendan also made significant contributions to the federal government’s response to SARS-CoV-2.

Megan Graham, VP or Regulatory & Quality, Orthogonal
Megan Graham is the Vice President of Regulatory and Quality at Orthogonal, bringing over 25 years of experience in software engineering and regulatory affairs. She has worked with leading organizations like Medtronic and Mayo Clinic, and founded her own digital health consulting practice in 2015. Megan’s expertise spans healthcare AI/ML, product development, risk management, and compliance strategies. As an adjunct professor at the University of Minnesota and active member of RAPS, HIMSS, and AAMI, she remains dedicated to advancing best practices in digital health.

Moderator

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).