Software Documentation: Best Practices
Software documentation can meet regulatory requirements although it is based on an agile development process. Our video will show you how!
Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.
The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.
Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.