Artificial Intelligence is rapidly transforming healthcare and medical technologies. While its potential is immense, the complexity it introduces poses real challenges for manufacturers and Notified Bodies alike.

This DQS-hosted webinar offers a focused deep dive into the Medical Device Regulation (MDR) and the new EU Artificial Intelligence Act — shedding light on their overlaps, critical gaps, and upcoming obligations. More than just an information session, it’s a dynamic exchange designed to align DQS with our customers and prospects, bringing clarity to the evolving regulatory landscape. Gain direct insights from industry experts, including Notified Body representatives, as we explore how AI impacts not only product design but also key supporting processes such as QMS, risk management, cybersecurity, and usability. 

 

What to Expect: 

  • Key trends and an overview of certified AI-enabled medical devices 
  • The evolving role of AI beyond the product — its impact on QMS, risk management, usability, cybersecurity, and more
  • Structured guidance for navigating regulatory uncertainty 
  • Achievements in harmonization: standards, guidelines, and best practices
  • Addressing common misconceptions and implementation challenges 
  • Conformity assessment and certification requirements under MDR and the AI Act 

With so much noise surrounding AI, this webinar is OUR opportunity to cut through the hype and gain practical, actionable insights from those shaping the future of regulated AI in healthcare. 

 

Save the Date and Secure Your Spot!

 


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Navigating AI in Medical Devices & Healthcare – From Hype to Harmonization!

Language : English

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