To prove the safety and performance of AI-based software as a medical device, there are special documentation requirements due to data management and model development.
Is it true that an agile approach to software development for software that is a medical device cannot be used in compliance with the MDR? The answer is: “No. This is not true.”
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Software like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.
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.
Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software.
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
Market access of medical software in the U.S. is quite different compared to Europe. Get insights about the principles.
Software documentation can meet regulatory requirements although it is based on an agile development process. Our video will show you how!