Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss...
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.
Please submit the form to watch the webinar:
White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
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