Medical devices are revolutionizing healthcare. These devices improve patient outcomes, from tracking and recording vitals to measuring glucose levels to supporting cardiac conditions. The future of ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. So, it’s probably a great time to revisit what I thought was going to shape the industry in ...

Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, emphasizing how clear and accurate Instructions for Use support patient safety, ...