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 Commission published a White Paper aiming to foster a European ecosystem of excellence and trust in AI and a Report on the safety and liability aspects of AI. The White Paper proposes:
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