SaMD Development and the Use of AI Tooling
While much attention has been given to AI-enabled medical devices, this session explores something equally important: How AI is embedded within the tools developers use to build those devices.
AI tooling is changing how medical device software is developed. But when these tools are used in regulated environments, safety, validation, and compliance become critical, and a new set of related (and interesting) challenges arises.
Join Orthogonal and SoftComply for a focused conversation about using AI tools responsibly in the development of SaMD and other medical device software. Our experts will explain how FDA and MDR guidance apply to AI-powered development tools, what risk and validation challenges they introduce, and how teams can adopt them safely without slowing innovation.
What We’ll Cover:
✔️ Understanding the Scope: The difference between AI in tooling to build medical device software vs. AI in medical device software and why it matters.
✔️ Risk & Validation: How to assess and maintain control when using tools like GitHub, Copilot or CodeRabbit.
✔️ Continuous Oversight: Keeping AI tools validated as they evolve while being regulated under ISO 13485 and 21 CFR 820.
✔️ Smart Adoption: Starting small, measuring outcomes, and facilitating innovation without triggering compliance issues.
✔️ Building the Right Mindset: Creating frameworks and cultures that make AI tools adoption safe and sustainable.
Who Should Attend?
▪️ Regulatory & Quality Leaders – Learn how AI tools fit within existing compliance systems.
▪️ Engineering & R&D Teams – Understand how to validate and manage AI-powered development tools.
▪️ Executives & Technical Leaders – See how to foster innovation while maintaining oversight and trust.
If your teams are experimenting with AI in development, this webinar will help you make informed, risk-aware decisions that support both compliance and innovation.
Sign up for the webinar here:
