The European Society of Cardiology (ESC) has urged the European Commission to revise the Medical Device Regulation (EU ...

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a ...

Parliamentary panel report calls for overhaul of medical device regulatory procedures to enhance transparency and sector ...

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...

Danish medical device company TOOsonix has formed a strategic collaboration with Consultronix to introduce its “focused” ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

The Global Handbook of Medical Devices Regulatory Affairs 2025 provides comprehensive, country-by-country insights into medical device regulations worldwide. Covering 70+ countries, it includes ...

Medical devices play a critical role in healthcare by enabling accurate diagnosis, effective treatment, and efficient ...

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...

To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations ...

Advanced Medical Solutions reported a 41% increase in revenue to £177.5m for the year ended 31 December on Wednesday, driven ...