#CE, #Europe, #MDR, #regulatory

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

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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

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