The 6th Medical Device Software Development Summit returns this July in Boston and brings together the specialists who are defining how AI-driven and software-based medical devices are built, validated, and submitted in an increasingly complex regulatory environment.

AI is accelerating innovation faster than traditional compliance models can keep up. FDA expectations for AI-enabled devices continue to evolve, cybersecurity scrutiny is intensifying, and global regulations such as the EU AI Act are adding new layers of complexity. The summit provides the clarity needed to navigate this shift by focusing on the real-world application of AI, automation, model development, and lifecycle management in regulated device environments.

Across three days of technical sessions and workshops, you will learn how leading teams are integrating AI responsibly, reducing regulatory risk, and strengthening product development pipelines. Speakers will break down practical frameworks for safe and compliant AI integration, including model validation, data quality, transparency expectations, documentation strategies, and global submission planning. Sessions also explore how continuous deployment and code generation tools can be aligned with compliance requirements.

You will:

• Gain clear insight into evolving FDA expectations for AI-enabled and learning devices
• Learn best practices for AI model development, validation, and deployment across the product lifecycle
• Explore cybersecurity architectures that protect AI-driven systems from emerging risks
• Understand how companies are modernizing development workflows through automation and AI-assisted engineering while maintaining compliance
• Benchmark with software, regulatory, quality, cybersecurity, and product leaders who openly share real-world implementations and lessons

With a focused senior-level audience, discussions are practical, detailed, and grounded in real use cases instead of high-level theory. If your team is building or validating AI-enabled medical device software in 2026, this summit is the most concentrated source of guidance on how to innovate safely, accelerate approvals, and future-proof your roadmap in a rapidly shifting landscape.

Join the community leading the next generation of AI-driven medical device software and gain the insight and tools needed to advance your program with confidence.

To learn more and register online, please click here.