AAMI TIR115 Is Here: What MedTech Teams Need to Know About Public Cloud Computing

Randy Horton

Published on: November 3rd, 2026

Medical devices heavily depend on public cloud infrastructure that manufacturers do not directly control. That creates new considerations for risk management, supplier management, architecture, testing, and ongoing change.

AAMI’s newly published TIR115:2026, Guidance for the appropriate use of public cloud computing to enable medical device functions, provides guidance for addressing those challenges. An application has also been submitted to the FDA for consideration of TIR115 as a recognized consensus standard.

Orthogonal played a leadership role in the development of TIR115. Chief Solutions Officer Randy Horton co-chaired the new AAMI Cloud Computing Working Group, and Orthogonal’s founder and CEO Bernhard Kappe and our VP of Regulatory & Quality Megan Graham also contributed significantly to the development of the guidance.

Join Orthogonal for a practical discussion of what TIR115 means for MedTech teams, what the new guidance says, and how manufacturers can begin applying it to cloud-based medical devices.

What You’ll Learn

Understand Indirect Control: Learn how to identify and manage cloud resources your device depends on when they are operated and changed by a third party.
Define the Medical Device System and Digital Environment: Understand the difference between the Medical Device System (MDS) and the Medical Device Digital Environment (MDDE), and why that boundary matters.
Apply Risk-Based Cloud and Supplier Management: Explore how to evaluate whether cloud resources are appropriate for a device function and how to manage cloud service providers within your quality system.
Design for Continuous Change: Learn how architecture, testing, change control, and postmarket monitoring can help manage cloud environments that change frequently.

Who Should Attend?

Executive & Business Leaders responsible for digital strategy, connected products, and cloud investment.
Product, Software, Systems & R&D Leaders designing SaMD, connected devices, or cloud-enabled product architectures.
Quality, Regulatory & Risk Leaders responsible for supplier management, validation, change control, and risk management.
Cloud, DevOps, IT & Cybersecurity Leaders responsible for infrastructure, deployment, reliability, security, and postmarket operations.

Register for TIR115 Webinar

After the Webinar

Beyond the Cloud: Indirect Control as the New Paradigm for Medical Device Software: Explore how the concept of indirect control extends beyond public cloud computing to third-party AI, smartphones, and other technologies that medical devices depend on.
AAMI Publishes TIR115: New Guidance for Using Public Cloud Computing in Medical Devices: Get an overview of the newly published TIR115 guidance, its key principles, and what it means for MedTech manufacturers.
AAMI TIR115 Cloud Guidance for Medical Devices: Learn how Orthogonal helps MedTech teams apply TIR115 to cloud architecture, risk management, supplier oversight, testing, and ongoing change.

Building a Cloud-Enabled Medical Device?

Understand what AAMI TIR115 means for your cloud architecture, risk management, and regulatory strategy. Talk with Orthogonal about applying the guidance to your medical device.

Book a Cloud Readiness Conversation

Bernhard Kappe orthogonal software as medical device

Randy Horton, VP of Solutions and Partnerships, Orthogonal