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あらすじ・解説
How are the regulatory landscape and market compliance practiced when determining the safety of AI software that would impact healthcare globally? Digital Health Thought Leader, Rudolf Wagner, tells us how.
To connect with Rudolf, connect with him on LinkedIn here.
Key Takeaways:
1. Germany has a two-fold regulatory environment for software as a medical device. The first is those who produce AI for clinical use, and then what happens in the hospital.
2. When a major situation occurs, there is a change to a more strict regulation.
3. Software is measured in a matter of days and not years and the current regulatory environment needs to get ahead of the market or allow people to be on their own.
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