Audience
Medical device companies, digital health startups, and healthcare technology teams that need to develop compliant, scalable software for connected medical devices and digital therapeutics
About Orthogonal
Orthogonal provides specialized development services focused on building and scaling Software as a Medical Device (SaMD) and connected medical device systems, combining modern engineering practices with strict regulatory compliance. Their approach spans the full product lifecycle, including user experience design, human factors integration, requirements definition, risk analysis, Agile software development, and verification and validation to ensure both functionality and safety. It emphasizes the use of Agile methodologies adapted to regulated environments, enabling iterative development, faster feedback cycles, and continuous improvement while maintaining compliance with standards such as FDA, EU MDR, and ISO frameworks. Orthogonal supports the development of mobile, web, and desktop applications, cloud-based systems, AI algorithms, and SDKs that integrate with third-party platforms, allowing medical devices to connect, process data, and deliver insights.