Cook Medical announced that it launched its NestVT vitrification device for in-vitro fertilization (IVF) in the U.S.

It’s an iterative process because risk never disappears, and products must continuously evolve to new standards.

Does more regulation mean fewer devices? Surveys show device companies facing new EU rules are pruning their portfolios.

The security guidelines cover five stages of the AI lifecycle to help mitigate varying risks of AI implementation.

It has only been modified to comply with this publication’s space and style. When equipped with the new device stabilizer, each station of the rotary labeler features two prongs that hold the pens in ...

Many companies don’t realize that everything, from your website to social media posts, qualifies as promotional labeling and must comply with FDA and FTC regulations. The Importance of Compliance in ...

The voluntary scheme, launched officially on Oct 16, will rate the devices according to their level of cyber-security ...

We’ll start with stroke detection innovator EMvision Medical Devices (ASX:EMV), which expects to release the results of a ...

Medical device companies are dealing with the impact ... s rise to superstar status and the risks associated with its off-label use. In the age of AI, large data sets – like the treasure trove ...