Medical Devices (includes In Vitro Diagnostics)

Applied

Regulatory Challenges of Real-World Artificial Intelligence (AI) and Machine Learning (ML) in MedTech

Session Leader(s)

• 

  Pamela Weagraff, MBA

  Director, MedTech Regulatory
  Quintiles

Speaker(s)

• 

  Pat Baird, MBA, MS

  Global Software Standards
  Philips
• 

  Samir Shah

This session will engage MedTech professionals looking to understand the regulatory challenges of software as a medical device (SaMD) with special focus on AI/Machine Learning (ML). This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what’s next for AI and ML as SaMD will be explored.

 

Learning Objectives:

• Describe actual and future AI applications that are changing patient treatment and healthcare delivery through the exploration of real-world examples (across different diagnostic/therapeutic and technology areas).
• Demonstrate knowledge of US and EU perspectives on current developments and challenges stemming from the development and implementation of AI/ML in development of regulatory strategies.
• Develop and execute regulatory strategies that meet real-world needs posed by AI and ML.