Developing guidance on factors affecting data quality regarding AI as a medical technology.
Establishing a common set of criteria for the deployment of AI in healthcare systems that could be used as an evaluation protocol by multiple stakeholders, covering organizational management, professional conduct, research and ethics, evidence-based practice, and data governance.
Developing risk management guidance to assist in applying ISO 14971 to AI as a medical technology.
Developing guidance on factors to consider in the validation of AI systems and on the use of non-traditional approaches, such as excellence assessments, to demonstrate a reasonable assurance of product quality.
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About AAMI
AAMI is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.
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