Risk Management of AI/ML Software as a Medical Device (SaMD): On ISO 14971 and Related Standards and Guidances

Abstract

Safety and efficacy are the paramount objectives of medical device regulation. And in line with the medical ethos of non-maleficence, first do no harm, safety is the primary goal of regulation also. As such, risk management is the underlying principle that governs the regulation of medical devices, whether traditional devices or Software as a Medical Device (SaMD). In this article, I review how Risk Management Standard ISO 14971:2019 both connects with and serves as a foundation for the other parts of the Artificial Intelligence (AI)/Machine Learning (ML) SaMD regulatory framework.