Webinar – 2024 IVDR Sprint Series: Usability and Human Factors: Cornerstones of Near Patient Testing – Insights and Perspectives from a Notified Body

Webinar – 2024 IVDR Sprint Series: Usability and Human Factors: Cornerstones of Near Patient Testing – Insights and Perspectives from a Notified Body

Usability and Human Factors in Near Patient Testing Devices

Near-patient testing (NPT) devices face substantial challenges under the new IVDR, including:
  • New Stringent Regulatory Constraints due to IVDR
  • Risk-Based Approach for Usability and Human Factors, including Use Environment
  • Expectations from Notified Bodies
In this recorded webinar, Lydie Moreau and Juan Roman from Veranex, and Laura Scrivano from TÜV SÜD GmbH help you to:
  • Acquire insights into the landscape requirements of the In-Vitro Diagnostic Regulation (IVDR) related to Near Patient Testing.
  • Comprehend how usability, human factors and use environment support in fulfilling regulatory obligations associated with the compliance of IVDs in the EU market.
  • Receive input from a Notified Body on gaps observed and expectations.

 

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