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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Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.