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.
翻译：安全性和有效性是医疗设备管理的首要目标。根据非男性医疗精神,首先不造成伤害,安全也是管理的首要目标。因此,风险管理是规范医疗设备管理的基本原则,无论是传统设备还是作为医疗设备的软件(SAMD ) 。在本条中,我回顾了风险管理标准ISO 14971:2019如何与人造情报(AI)/Machine Learning(ML) SaMD监管框架的其他部分相联系,并以此作为其基础。
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