Cloud for Medical Devices
Leverage the Cloud’s Power While Ensuring Regulatory Compliance
Cloud computing gives medical device companies tremendous power and flexibility, while also challenging traditional approaches to design control, risk management and software assurance. As developers of cloud-based medical device software and contributors to AAMI TIR115, Orthogonal helps companies take advantage of the cloud while managing the unique quality and regulatory considerations it introduces.
Benefits of Cloud
On-demand scaling of medical device software, algorithms and support infrastructure.
Cloud computing enables software to easily and quickly scale based on real-time demand. Fierce competition among cloud providers leads to services that are continuously updated and improved, making the cloud more reliable, robust and secure than what an individual company could build on their own. With the right approach, one can move medical device software that may otherwise live in a physical device or an internally maintained data farm onto cloud infrastructure to take advantage of the cloud’s overwhelming strengths.
Challenges of Cloud
Highly regulated software meets a continuously evolving environment.
Placing medical device software on the cloud involves relinquishing control over the environment it runs in. As the underlying cloud infrastructure is continuously changing, maintaining software assurance and validation for medical device software becomes a challenge, particularly in the context of traditional software validation paradigms. Orthogonal is at the forefront of reshaping this paradigm to help medical device companies overcome these challenges.
Our Cloud Leadership
Helping shape industry guidance for public cloud computing in medical devices.
Orthogonal has played a leading role in AAMI’s work on the use of public cloud computing in medical devices. Chief Solutions Officer Randy Horton co-chaired the AAMI Cloud Computing Working Group alongside Pat Baird of Philips, and Orthogonal Founder and CEO Bernhard Kappe and VP Regulatory and Quality Megan Graham served as a member of the working group.
In 2026, AAMI published TIR115:2026, Guidance for the appropriate use of public cloud computing to enable medical device functions. The new Technical Information Report provides practical guidance for identifying and managing the risks that arise when medical devices depend on public cloud infrastructure that manufacturers do not directly control.
Clouds We Work On
Leveraging our familiarity with Amazon Web Services, Microsoft Azure and Google Cloud Platform.
Orthogonal has experience working with the three major cloud providers: Amazon Web Services (AWS), Microsoft Azure and Google Cloud Platform (GCP). Each provider has its advantages and disadvantages. We’ll help you in selecting the right platform that suits the unique requirements of your medical device software solution.
Ecosystem Development
Supporting your device with our end-to-end product development expertise.
Orthogonal builds scalable medical device ecosystems that encompass device connectivity (Bluetooth, cellular, etc.), mobile and web applications, cloud-deployed AI and ML models and cloud services supporting hundreds of thousands of devices and users. Our expertise extends beyond knowledge of each technology and into how they can be architected to work together in a compliant manner. We’ll help your company create an end-to-end ecosystem that ensures regulatory compliance for your medical device in our interconnected world.
Start Your Cloud Conversation
Build and manage cloud infrastructure that supports safe, effective medical device software.
Whether you are building a new cloud-enabled medical device or evaluating an existing architecture against TIR115, Orthogonal can help. We bring together cloud architecture, medical device software development, risk management and quality-system expertise to help you build, evolve and manage cloud-based medical device systems with confidence.
Our Cloud Readiness Assessment can also help you understand where your current approach stands against TIR115 and prioritize what to address next.
