In the United States, medical devices are regulated by the FDA. In the European Union, medical devices are...
Software
Regulating Software
Medical devices have advanced beyond the point of simple machinery. Software has begun playing an important...
The UK’s AI/ML Medical Device Plan
The FDA has begun tackling AI/ML software as a medical device (SaMD) this year, but there was a noticeable...
Software Systems: Medical Device or Not?
The 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
Elements to Consider for Risk Assessment in SaMDs
Users might get frustrated with software systems in the healthcare sector due to less compact UIs or functionality...
Is Electronic-IFU an Option?
Changes in technology call for changes in the ways we use that technology. This means that the instructions for use...
The Do’s and Don’ts for Medical Software Development
For any software development, there is a defined pattern. What I like to do is always start with the identification of...
Medical Devices Used to Treat Heart Conditions
EMMA International celebrates February in recognition of American Heart Association Month and we bring you an...
Software Tools as Medical Devices in 3D Printers
While going through my daily tech-news, I came across an interesting piece of research relating to 3D printing....
Caption Guidance – FDA’s First Authorized AI-Based Cardiac Ultrasound Software
Happy American Heart Association month, everyone! While celebrating this month at EMMA International, we bring you...
Prioritizing Cybersecurity in the Med Device Industry
The FDA is in a constant state of working to optimize regulatory requirements for advancing technology. Digital health...
Mobile Applications for Heart and Blood Pressure Monitoring
Nowadays, there are mobile applications for almost every utility and in every domain. From e-commerce, finance,...
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