Software As a Medical Device That Fits Into Patients’ Lives

Orthogonal’s approach combines Agile methods and regulatory compliance to build, evolve and scale powerful SaMD and connected device systems that fit into patients’ day-to-day lives and improve real-world health outcomes.

We Tackle the Most Complex SaMD Challenges

Engaging Patient Apps

We create apps that are easy to use and rewarding, and we mine product analytics to continually improve experience and engagement.

Rapid & Frequent Releases

Our approach allows our clients to readily launch frequent, high-quality releases, improving functionality while maintaining regulatory compliance.

Regulatory Compliance

Our QMS is ISO 13485:2016 certified, ensuring that SaMD and connected device systems are built and documented with compliance and safety in mind.

Want to Learn How We Do It?

Some of Our Customers

Google Logo Roche Logo Eli Lily Logo Novo Nordisk Logo Medtronic Logo Tandem Diabetes Logo Nanowear Logo Boehringer Ingelheim Logo physIQ Logo metaMe Logo Habitnu Logo

What Our Clients Say

“Orthogonal brought us the expertise we needed to ensure our technology platform met the high standards of the FDA. Through their involvement, we absolutely accelerated our pace through the regulatory process. ” Gary Conkright CEO of PhysIQ
“We needed a SaMD partner equally versed in medical device software development and modern software engineering. Orthogonal clearly crosses that bar, and has been an invaluable asset for Boehringer Ingelheim Digital.” janet maldonado headshot Janet Maldonado Head of Engineering, Boehringer Ingelheim Digital
“Applying modern engineering techniques to the development of SaMD is no easy feat. Orthogonal’s approach to blending these domains helped Tandem accelerate our product innovation cycle and outputs” Larkin Lowrey, Senior Director of Software Engineering for Digital Health, Tandem Diabetes Larkin Lowrey Senior Director of Software Engineering, Tandem Diabetes Care

Case Studies

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Continuous ECG Monitoring with Nanosensors

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PhysIQ: Ambulatory Patient Monitoring

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Diabetes Management System

Case Study

Percutaneous Tibial Nerve Stimulation