Navigating Global AI Healthcare Regulations & Quality Requirements: Current Trends & Future Perspectives

Event Time

Originally Aired - Wednesday, October 16 11:15 AM - 12:00 PM Central Time (US & Canada)

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Event Location

Location: Room 103 A


Event Information

Title: Navigating Global AI Healthcare Regulations & Quality Requirements: Current Trends & Future Perspectives

Session Handouts Available at Speaker Approval: 1

Description:

Artificial Intelligence (AI) has garnered a lot of interest, with questions on how to build safe and trustworthy AI systems in the medical device industry. 

What questions do we need to ask about using AI in medical devices? And how do we ask them? What are current regulatory expectations? I will be using examples to explain the 'how' and considerations to be taken into account from a quality and regulatory perspective while demystifying regulatory/quality concepts related to AI used in medical device products through a template-based case study.

By the end of this session, participants will be able to:

  • Go back to your organization and lead decision making on AI-enabled medical devices in a cross-functional setting

  • Provide examples of how AI can be used in the healthcare industry

  • Understand how countries across the world are regulating AI
  • Speak to key quality considerations regulators seek to be addressed (even if you are not a regulatory/quality nerd) 
  • Bring back cross-functional critical thinking techniques on AI to your organization to make more informed decisions
  • Develop risk-based thinking for AI development and deployment in a healthcare setting
  • Learn about regulatory and quality questions to think about when building your own AI enabled medical device
  • Ask context-specific questions to test your AI model on various principles

Type: Case Study


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Education Level

  • All

Pass Type

  • 1 Day MD&M Conference Pass (Wednesday)
  • 2 Day MD&M Conference Pass
  • Media
  • Speaker

Session Theme

  • Artificial Intelligence (AI)
  • Digital Health
  • Quality & Regulatory
  • MD&M: Medical Regulatory & Quality Requirements

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