In this article, we discuss what manufacturers must pay attention to when considering the software lifecycle and how the standards specifically help in this respect.
The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process.
VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.
Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software.
Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards.
The use of patient diaries for telemonitoring often fails due to a lack of compliance. The use of speech recognition can increase patient compliance.
It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
