  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.
