Learn how IVDR aligns with FDA standards, where they diverge, and how to use your IVDR compliance as a springboard for global IVD market access.
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This article offers a breakdown of the three key pillars of clinical evidence: scientific validity, analytical performance, and clinical performance. Clear guidance on tailoring your approach based on device risk class and type is provided, along with best practices for evaluating the state of the art and integrating it into your performance evaluation. It clarifies postmarket performance follow-up (PMPF) requirements and how they support your benefit-risk assessment.
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El impacto del IVDR de la UE en los ensayos clínicos \| QbD Group
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La inteligencia artificial (IA) y el aprendizaje automático (ML) están en auge en el sector de los productos sanitarios y el IVD. Obtén más información sobre el panorama actual y el marco normativo aquí.
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Even with the European Commission's proposal for extending the transitional period for IVDs, manufacturers should start building compliant Technical Documentation now.
Read moreUnderstanding the impact of EU IVDR on clinical trials and the changes it brings. Stay informed and compliant with the latest regulations.
Read moreArtificial intelligence (AI) and machine learning (ML) are on the rise in the medical device and IVD industry. Learn more about the current landscape and regulatory framework here.
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