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MedTech Summit US

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December 6 - 8, 2022
Intercontinental Chicago Magnificent MileChicago, IL

December 6 - 8, 2022
Intercontinental Chicago Magnificent Mile,
Chicago, IL

Global Medical Device Regulations: Unlock New Opportunities & Accelerate Device Certifications

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

Dive into critical regulatory frameworks, EU MDR, UKCA, UDI, real-world evidence, post-market surveillance and more...

Break-through the Regulatory Hurdles and Pave the Path to Successful Medical Device Submissions Across the Global

Addressing EU Medical Device Regulation Compliance Concerns

  • Industry experiences of submitting under EU MDR from Novartis and BD
  • Addressing capacity concerns – current capacity status, methods to address and debating plan B
  • Hear from George Faithful on the current status of implanting Real World Evidence on a global scale

Global Regulatory Landscape and Access Pathways

  • IMDRF Keynote from FDA
  • Understanding current status of UKCA mark and regulatory expectations with ABHI
  • Detailing access pathways for APAC with Organon and Varian Medical Systems

Medical Device Lifecycle Guidance: Pre to Post Market

  • Importance of consistency in intended purposes as detailed by NSAI
  • Best practices for aligning clinical evaluations and risk management processes
  • Explore tips on creating PSURs, PMCFs, Systematic Literature Reviews and more with industry thought-leaders