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AAMI TIR115:2026
Guidance for the appropriate use of public cloud computing to enable medical device functions
The purpose of this document is to provide guidance to multiple stakeholders on the appropriate use of public cloud computing in support of the operation of regulated medical devices. Cloud service providers, medical device manufacturers, regulatory professionals, and regulators should be able to use this document to identify best practices that ensure the public cloud computing environment underlying medical devices works within the spirit and the letter of regulations designed to improve patient outcomes, while also being safe and effective. This TIR supersedes AAMI CR510:2021; Appropriate use of public cloud computing for quality systems and medical devices.
Association for the Advancement of Medical Instrumentation [aami]