OrthogonalFDA Software Precertification: A Working Guide for Medical Device CompaniesThe Food & Drug Administration’s Software Precertification Program represents a fundamental paradigm shift in the regulation of medical…Jul 22, 2019Jul 22, 2019
OrthogonalSoftware as a Medical Device (SaMD): What It Is and Why It MattersThe World Health Organization (WHO) reports that there are around 1.5 million medical devices globally, across more than 10,000 types…Jun 5, 2019Jun 5, 2019
OrthogonalOrthogonal Obtains ISO 13485 Certification for Medical Device SoftwareOct 5, 2017Oct 5, 2017