IVDR Performance Evaluation
Автор: ProductLife Group
Загружено: 2025-04-24
Просмотров: 175
Bringing an IVD medical device to market requires robust performance evaluation to meet regulatory expectations. But how can manufacturers efficiently demonstrate clinical evidence, especially for legacy devices?
Introduction to performance evaluation – A key factor in IVD market access
Demonstrating IVD performance – Clinical evidence requirements
Focus on legacy devices – Leveraging available data for compliance
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