AI refers to the ability of machines to perform tasks that normally require human intelligence – for example, recognizing patterns, learning from experience, drawing conclusions, making predictions, or taking action – whether digitally or as the smart software behind autonomous physical systems
As of right now, there is no globally recognized standard regarding AI & ML in Medical Devices of Healthcare.
There are multiple working groups, developing standards for all industries: Foundational standards (terminology, framework); Big Data (vocabulary, reference architecture); Trustworthiness (risk, robustness, bias); Use cases & applications; AI Governance.
Whether using a predictive (Waterfall; V- model) or adaptive methodology (Agile), it is imperative that the following processes and their corresponding outputs to be incorporated in the SaMD Development:
Manufacturers of SaMD must report any correction or removal of an SaMD if action was initiated to:
The European Commission put forward a European approach to Artificial Intelligence and Robotics. It deals with technological, ethical, legal, and socio-economic aspects to boost the EU's research and industrial capacity and to put AI at the service of European citizens and the economy.
The European Trade Association COCIR posted their position paper regarding AI in healthcare.
Also, you may want to review Knowledge Centre Data & Society (2020) “Feedback on EC White Paper on Artificial Intelligence“
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Key documentation on Artificial Intelligence and Machine Learning within Medical Device space