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…19 min read·Jul 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…17 min read·Jun 5, 2019----
OrthogonalOrthogonal Obtains ISO 13485 Certification for Medical Device Software2 min read·Oct 5, 2017----