Artificial intelligence can be defined as “[a] machine’s ability to make decisions and perform tasks that simulate human intelligence and behavior.“
Artificial intelligence in medical devices is employed to fulfill human capabilities in a variety of roles with deep learning techniques using neural networks, which include, but are not limited to:
- Prediction and identification of diseases
- Data classification and analysis for disease outbreak
- Optimization of medical therapy
- Diagnostic support application
BioReg possesses leading competence in assessing AI, software in medical devices & digital health medical devices, and applications in general. With a sound understanding of the regulatory safety and performance standards, we assess if manufacturers meet the state-of-the-art requirements of AI-driven medical devices to minimize regulatory compliance issues during certification and surveillance audits and technical documentation.
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