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.
“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 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, Tandem Diabetes
Case Study
Case Study
Case Study
Case Study
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.
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.
