Orthogonal LLC

Orthogonal is a Cambridge-based, privately-held services and consulting firm founded in 2018, specializing in the development of regulated digital health software. The company operates as a strategic partner for venture-backed startups, established medical device firms, and pharmaceutical companies, providing end-to-end expertise in building compliant SaMD and connected device systems. Its core value proposition lies in its unique integration of Agile development practices with stringent quality and risk management frameworks (ISO 13485, IEC 62304, ISO 14971), enabling clients to accelerate product development and scaling. Orthogonal is revenue-generating, with a business model centered on providing high-value software engineering and regulatory strategy services.

Integrated service methodology combining Agile software development, regulatory compliance (ISO 13485, IEC 62304, ISO 14971), and technical expertise in connected devices, mobile apps, cloud, AI/ML, and healthcare interoperability to build and scale SaMD and connected medical device systems for clients.

Orthogonal competes in the digital health development services space against other specialized regulatory consultancies, boutique software agencies with medtech experience, and the digital practices of large IT consulting firms. Its key differentiator is its proven, certified fusion of Agile development with full regulatory lifecycle and risk management, a niche that demands rare cross-disciplinary expertise.