About
Orthogonal provides consulting and professional services to design, build and recover software-enabled medical devices and SaMD. Their approach combines Agile methods with regulatory compliance to develop SaMD and connected device systems. Orthogonal states its Agile approach is compliant with FDA and EU quality systems regulations and standards including IEC 62304, AAMI TIR45 and ISO 14971, and it weaves verification and validation and risk management into development. They use user research, product analytics, automated integration testing and human factors inputs, and apply cybersecurity risk analysis, hardware/firmware evaluation and software segregation techniques. Orthogonal offers project assessment, root-cause analysis and remediation to help devices meet regulatory documentation and development quality expectations.
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