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Regulation, Clinical and Software for Medical Devices


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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota
November 5 - 7, 2024
The Royal Sonesta Minneapolis Downtown,
Minneapolis, Minnesota

Are you capitalizing on the evolving global medical device software and AI landscape?

Critical Feedback from the US FDA, Notified Bodies and Leaders in the Industry on Ensuring Compliance with the SaMD and SiMD Requirements

Global Regulatory Pathways. Lifecycle Management. Cybersecurity.

Get to grips with the latest MedTech Software and AI regulatory updates

Timely Regulatory Authority and Notified Body Perspectives:

  • Regulatory Authority and Notified Body feedback on the current status of SaMD, SiMD and artificial intelligence regulations
  • Regulatory update on EU and US markets from FDA
  • Understand the Notified Body perspective on SaMD and SiMD regulations with GMED North America

Case Studies on Market Access and Device Life-Cycle Management:

  • How can you achieve faster market access with medical devices involving software and AI?
  • Explore key considerations for audits with Silver Lake Group
  • Arthrex share their approach towards life-cycle management

What’s In Store for Software/AI Now, and In the Future?

  • Key industry perspectives on maintaining compliance and adhering to software and AI regulations
  • Feedback from Teva Pharmaceutical on clinical decision support software
  • An assessment of the future of software and AI regulations with Teva Pharmaceuticals, Arthrex and Philips