November 5 - 7, 2024
The Royal Sonesta Minneapolis Downtown,
Minneapolis, Minnesota
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.
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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