The renowned firm offers ISO 13485 certification consulting services to its customers.

BD (NYSE: BDX) announced today that it launched a new hemodynamic monitoring platform using predictive AI algorithms.

The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development ...

Tidepool, a nonprofit organization dedicated to empowering the diabetes community through open-source innovation, proudly announces it has achieved ISO 13485:2016 certification from accredited ...

From El Paso, Texas, to Richmond, Virginia, medical device warehouses are leaking ethylene oxide, a cancer-causing chemical.

There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical ...

Imricor receives CE Mark certification for the Advantage-MR system under new European Medical Device Regulation as it hits world first ... Read More The post Imricor wins European assent for its world ...

An NBC News investigation that exposed how corpses were used for research without consent prompted Texas legislators to push ...

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

The IMDRF have recently published key concepts and principles for the development of high-quality medical devices which ...

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...