Risk Management for Medical Devices | Orthogonal

222 W Merchandise Mart Plaza #228, Chicago, IL 60654
(312) 374-6490
https://maps.app.goo.gl/KqJjFDewKpFXk63P7

Mitigate patient risk early and efficiently with Orthogonal’s medical device risk management services. Our integrated approach complies with ISO 14971 and IEC 62304 while fitting seamlessly into Agile development. We combine human factors engineering for use-error reduction, cybersecurity for connected systems, and software segregation to prevent cascading failures. Rightsized techniques including hazard analysis, DFMEA, and Use FMEA scale to your software safety classification. We also design for interoperability with custom SDKs and documented residual risks. Whether you’re developing Software as a Medical Device (SaMD) or complex connected systems, Orthogonal helps you achieve regulatory compliance without sacrificing velocity. Contact us to build safety into every sprint.