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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

US FDA Updates and digital health regulations

Global Quality Requirements. 510K. Real World Evidence. Pre-cert Program. Cyber Security

highlights include:

US FDA requirements

  • Streamlining global quality requirements
  • 510K device approval
  • Scrutiny and inspection-readiness
  • Real World Evidence and reimbursement
  • Update on the Medical Device Single Audit Program (MDSAP)
  • Best practice for gaining product approval in the US and Europe

Software and Digital Health

  • FDA regulatory initiatives for software, digital health and AI
  • Pilot site experience on the software pre-cert pilot program
  • Focus on cybersecurity, cloud applications and hosting compliance
  • Go-to-market strategies and regulatory approaches for software
  • Operationalizing security, quality and risk management best practice

Industry perspectives from:

  • Philips
  • Pear Therapeutics
  • Roche Diagnostics
  • Pfizer
  • GE Healthcare
  • Sanofi Medical Devices
  • Hillrom
  • BD