Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….
In the United States, medical devices are regulated by the FDA. In the European Union, medical devices are...
Medical devices have advanced beyond the point of simple machinery. Software has begun playing an important...
The FDA has begun tackling AI/ML software as a medical device (SaMD) this year, but there was a noticeable...
The 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
Users might get frustrated with software systems in the healthcare sector due to less compact UIs or functionality...
Changes in technology call for changes in the ways we use that technology. This means that the instructions for use...
For any software development, there is a defined pattern. What I like to do is always start with the identification of...
EMMA International celebrates February in recognition of American Heart Association Month and we bring you an...
While going through my daily tech-news, I came across an interesting piece of research relating to 3D printing....
Happy American Heart Association month, everyone! While celebrating this month at EMMA International, we bring you...
The FDA is in a constant state of working to optimize regulatory requirements for advancing technology. Digital health...
