Regulatory Affairs4 jun 2025 4 min
Can IVDR Be Your Global Regulatory Compass for Market Entry?
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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Regulatory Affairs26 mar 2025 2 min
Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR
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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Clinical21 mar 2025 1 min
El impacto del IVDR de la UE en los ensayos clínicos
El impacto del IVDR de la UE en los ensayos clínicos \| QbD Group
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Software Solutions & Services20 feb 2025 6 min
La llegada de la inteligencia artificial y el aprendizaje automático a los productos sanitarios
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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Regulatory Affairs23 abr 2024 2 min
Why start building IVDR-compliant Technical Documentation now?
Even with the European Commission's proposal for extending the transitional period for IVDs, manufacturers should start building compliant Technical Documentation now.
Leer másRegulatory Affairs24 mar 2024 1 min
The Impact of EU IVDR on Clinical Trials
Understanding the impact of EU IVDR on clinical trials and the changes it brings. Stay informed and compliant with the latest regulations.
Leer másSoftware Solutions & Services9 dic 2022 6 min
The Advent of Artificial Intelligence and Machine Learning in Medical Devices
Artificial 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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