Blog
Transition to MDR
The aim of Medical Devices Regulation 2017/745 (MDR) revision is to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety
Esther Kott
July 4, 2023
Breakthrough Devices Program
What is a Breakthrough designation? The FDA Breakthrough Device Designation is a formal identification by the US FDA that a device in development should be expedited for patient access because
Liat Diamant-Porat
June 16, 2023
