Talk
Emerging AAMI Cloud Change Control Guidance: Webinar
Community Roundtable: SaMD, The Cloud & TINY GVS
2026 Update: The work discussed in this 2022 roundtable ultimately contributed to AAMI TIR115:2026, Guidance for the appropriate use of public cloud computing to enable medical device functions. TIR115 supersedes AAMI CR510:2021 and expands the guidance for medical device manufacturers using public cloud computing.
The cloud is an incredibly powerful tool for Software as a Medical Device (SaMD), but it also changes the traditional control model. Medical device manufacturers may depend on third-party cloud providers that can make changes to the operating environment outside the manufacturer’s direct control, creating new considerations for safety, risk management, and validation.
Orthogonal’s VP of Solutions and Partnerships, Randy Horton, has helped draft the first industry guidance for the responsible hosting of SaMD on the cloud, and coined the concept of “This Is Not Your Grandmother’s Validated State” – aka TINY GVS – which challenges us to redefine the nature of software validation in an increasingly interconnected world.
On August 10, 2022, Randy joined fellow SaMD experts for a Greenlight Guru community roundtable exploring cloud computing, TINY GVS, and a more modern approach to software validation and device safety.
The discussion covered:
- The current state of cloud computing and the big three providers – Amazon Web Services, Google Cloud and Microsoft Azure.
- How those public cloud service providers can be leveraged in the operation of connected medical device systems, SaMD and Digital Therapeutics (DTx).
- The six key recommendations of AAMI CR510:2021 and how to implement them to ensure responsible and compliant use of the cloud for SaMD.
- How you can use TINY GVS to modernize your approach to the concept of the validated state.
- How the work started in AAMI CR510 was expected to evolve into more detailed guidance, which ultimately became AAMI TIR115:2026.
This will be an interactive discussion featuring multiple experts in MedTech, SaMD and cloud computing. Expect a lot of learning interspersed with friendly banter and a few pop culture references.
From CR510 to TIR115
The questions explored in this 2022 roundtable continued through the AAMI Cloud Computing Working Group and ultimately led to the publication of TIR115 in 2026.
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