“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. ”
Case Study
Our Approach
Build, Evolve, Scale
Orthogonal is uniquely qualified to help you take advantage of the rapidly expanding opportunities presented by digital technologies. We enable you to not just build the right products faster, but to evolve faster and scale faster than your competitors.
Who We Work With
Some of Our Customers
What Our Clients Say
“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.”
“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”
Case Studies
Case Study
Neurostimulation Device for Dry Eye Disease
Case Study
Continuous ECG Monitoring with Nanosensors
Case Study
PhysIQ: Ambulatory Patient Monitoring
Our Technologies
Bluetooth. Mobile apps. Machine Learning.
FHIR & EMR Integration.
These technologies are our bread and butter. We have over 10 years of experience in SaMD and connected devices, so when an issue arises, there’s a good chance we’ve faced it before – and know exactly how to handle it.
White Papers
White Paper
Bluetooth for Medical Devices
White Paper
Software as Medical Device: What It Is & Why It Matters
White Paper
AI & Medical Devices
eBook
Agile in an FDA Regulated Environment
Certifications & Compliance
Compliance to Global Standards
Orthogonal’s Quality Management System is certified by BSI to ISO 13485:2016. Our Agile processes are compliant with IEC 62304, AAMI TIR:45, and ISO 14971, as well as FDA QSR, EU MDR, GDPR and HIPAA.
