AAMI CR34971:2022 – Guidance on AI/ML & ISO 14971
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FREE PREVIEW (First 5 Pages) ✔ First 5 pages free to download · No email required · Full document available after purchase This AAMI consensus report, CR34971:2022, provides crucial guidance on applying ISO 14971 to the rapidly evolving fields of Artificial Intelligence (AI) and Machine Learning (ML) within health technology. It addresses the unique challenges and considerations when assessing and managing risks associated with AI/ML-driven medical devices and systems. This report is essential for manufacturers, regulators, and healthcare professionals involved in the development, evaluation, and deployment of these technologies. The first five pages are available for free preview. Topics covered include risk management frameworks, data quality, algorithmic bias, and validation strategies for AI/ML applications in healthcare.
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