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 EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.
The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.