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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The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.
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.
Software documentation can meet regulatory requirements although it is based on an agile development process. Our video will show you how!
