U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systemsstandard by Association for the Advancement

Infusion Technology and Therapystandard by Association for the Advancement of Medical Instrumentation, 01/01/1983

Principles for medical device security - Risk managementstandard by Association for the Advancement of Medical Instrumentation, 06/05/2016

Design of training and instructional materials for medical devices used in non-clinical environmentsstandard by Association for the Advancement of Medical Instrumentation, 03/19/2013