Orthogonal

Chicago, Illinois, United States

Medical device software development and regulatory compliance

Orthogonal specializes in the design and development of medical device software, focusing on Software as a Medical Device (SaMD) and connected device systems. With a strong foundation in software, Orthogonal integrates Agile methods with regulatory compliance to create solutions that fit seamlessly into patients' lives.

The company offers a range of services including quality systems engineering, risk management, and user experience design. They leverage technologies such as mobile medical applications, Bluetooth Low Energy, and AI & Machine Learning to deliver value to venture-backed startups, medical device companies, and pharmaceutical enterprises.

Orthogonal's expertise is backed by certifications like ISO 13485:2016 and compliance with global standards such as IEC 62304 and FDA QSR. Their work with clients like HeartSciences and Boehringer Ingelheim Digital demonstrates their capability to build and scale medical device systems effectively.

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Orthogonal operates in Chicago, Illinois, United States serving clients locally and beyond. Agency List organizes firms by geography to help buyers understand the distribution of agencies across regions and markets.

Data notes

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