Cytotron® qualifies for FDA Breakthrough Devices Program

Incorporating human factors engineering (HFE) into medical device development is more than a regulatory requirement...

2019 RAPS Convergence conference examined issues such as CER and clinical data management challenges

Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite...

The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association,...