This whitepaper describes how AWS approaches machine learning (ML) in a regulated environment and provides guidance on good ML practices using AWS products.
This whitepaper takes into consideration the principles described in the Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) discussion paper.
This content has been developed based on experience with and feedback from AWS pharmaceutical and medical device customers, as well as software partners, who are currently using AWS products to develop ML models.