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

Global Medical Device Success: Navigating Regulations, Expanding Markets, and Ensuring Lifelong Compliance

Dive into EU MDR, Software as a Medical Device, AI/ML, UKCA, UDI, Clinical Evaluations & Investigations, Real-World Evidence, Post-Market Surveillance, Benefit Risk Analysis, and More...

Your Burning Questions Answered by Pioneers in the Medical Device Ecosystem from the IMDRF, US FDA, Notified Bodies, and Key Industry Representatives.

Break Through the Regulatory Hurdles and Pave the Way to Successful Medical Device Submissions Across the Globe

Secure Medical Device Certification in Global Markets

  • Identify necessary documentation to expedite access to the US market
  • Incorporate best practices for EU MDR compliance with help from industry representatives
  • Expand your global reach in the Swiss and UK markets through our multi-stakeholder panel

Share and Learn From Industry Best Practices to Tackle Device Submissions

  • Benefit from Agilent Technologies’ insights on labelling and UDI requirements
  • Determine eligibility for transition deadline extensions through a multi-stakeholder panel
  • Understand data collection and sufficiency expectations with Abbott, Intuitive Surgical, AKRA Team, and more…

Maintain Compliance Throughout the Entire Device Lifecycle

  • Compile technical documentation successfully with help from SGS North America
  • Determine a clear clinical strategy and prepare for audits with guidance from Philips
  • Navigate post-market surveillance and vigilance requirements with best practices from TERUMO