Impact of Artificial Intelligence and New Technology on Device Regulatory Compliance – Webinar Recording/Transcript
Harnessing the power of artificial intelligence (AI) and machine learning (ML) technologies for your medical devices has obvious benefits.
The challenge is in meeting regulatory requirements as you do so. How do you build sufficient objective evidence to support your AI/ML-enabled devices? And how do you demonstrate to the FDA that your use of AI/ML supports the quality system and/or production?
Those are the challenges. Challenges this presentation trains you to meet.
Scott Thiel, global head of regulatory policy and intelligence for Hologic, and Jeff Ballyns, director of regulatory strategic planning for innovation at Becton Dickinson and a veteran of the FDA’s Center for Devices and Radiologic Health (CDRH) share techniques you can use to provide objective evidence of compliance.
They also explain how you can leverage the power of AI/ML to help improve the safety and effectiveness of your devices.
- Where the AI/ML technology knowledge gaps are — in industry and the FDA — including what AI/ML can and cannot do when it comes to medical device quality, regulatory and compliance information
- Common issues and strategies for closing knowledge gaps, including how to optimize the use of AI and ML
- What to do differently — or not do differently — when it comes to integrating AI/ML into your quality system or production process, including how integration meshes with your SOPs
- What issues the FDA sees when reviewing premarket submissions and inspecting facilities with AI/ML-enabled medical devices and AI/ML that supports the quality system and/or production
It’s a delicate balance to maximize your devices with AI/ML while complying with decades-old regulatory schemes.
Meet Your Presenters
Scott Thiel has more than 35 years of experience in the medical device, health information technology, in vitro diagnostics and combination product industries. He joined Hologic in January 2021 as the global head of regulatory policy and intelligence. In this role, he drives the development of a global strategy and framework for regulatory policy and intelligence facilitating all global regulatory positioning.
As director of regulatory strategic planning for innovation at Becton Dickinson (BD), Jeff Ballyns is responsible for assessing, communicating and strategically implementing new regulatory requirements impacting BD businesses. Prior to BD, Ballyns worked in CDRH for eight years, serving as a lead reviewer, branch chief and division director in the Division of Radiological Health within the Office of In Vitro Diagnostics and Radiological Health. While there, he was responsible for the premarket review and postmarket regulation of radiological imaging devices and AI image analysis software applications.
Who Will Benefit
- Regulatory affairs personnel
- Quality assurance professionals
- Regulatory policy professionals
- Software developers
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March 15, 2023