AAMI CR510:2021 PDF

The purpose of this document is to provide guidance to multiple stakeholders regarding the appropriate use of public cloud computing both as a component of medical devices and in support of quality systems. Cloud technology providers, medical device manufacturers, regulatory professionals and regulators alike should be able to refer to this document to identify known best practices for ensuring that the public cloud computing component of any medical device (or quality system) works both within the spirit and the letter of regulations designed to ensure that medical devices improve patient outcomes and/or help manage healthcare costs, while also being safe and effective.