Medical

The European regulatory landscape for medical devices is undergoing a fundamental transformation toward simplification. On...

For years, medical device manufacturers have navigated the Medical Device Regulation (MDR) 2017/745 as if...

The European medical device landscape is at a critical juncture. In its comprehensive position paper...

For decades, many medical device manufacturers have relied on USP Class VI certification when selecting...

The European Database on Medical Devices, a key element of the European Union’s regulatory framework...

Clinical evaluation remains one of the most critical and challenging elements of medical device compliance....

The EU Medical Device Regulation (MDR, EU 2017/745) defines the regulatory framework for the design,...

ISO 10993-1:2025 update has been published 7 years after the previous edition on November 18,...