[FEATURED] Pharma, Device Groups Oppose FDA’s Planned Drug to Device Transition
Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to […]
[Ask the Expert] Safety and Performance (MDR)
This session’s topic: Safety and Performance Measures and Acceptance Criteria for MDR Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What […]
[FEATURED] How The MDR Is Making The EU Competitively Backward
Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU […]
