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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

Consolidate your IVDR Knowledge and Achieve Compliance with Confidence

Dive Into The Significant Changes Under Article 110(3), Companion Diagnostics, and EU IVDR Expert Panels

Connect with thought leaders including TÜV SÜD, Abbott, Agilent, and Thermo Fisher Scientific

Accelerate Your Path To EU IVDR Compliance With Expert Guidance

Multi-Stakeholder Perspectives

  • Optimizing transitions from IVDD to IVDR
  • Reflecting on 6 months post-IVDR date of application from TÜV SÜD
  • Navigating significant changes under Article 110(3)

Accelerating Your IVDR Compliance

  • Outlining the future of companion diagnostics on a global scale with Covington & Burling
  • Step by step guidance on successful IVDR submissions
  • Lessons from PECP and navigating expert panels by Thermo Fisher Scientific

Initial Feedback from Key Players

  • Case study example on completing technical documentation with Agilent
  • First hand experiences class D conformity assessment from TÜV SÜD
  • Conducting Clinical Trials in line with IVDR