Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and ...

For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations.

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

Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance ...