Brian is a Biomedical Engineer with deep experience of medical device development and medical device regulations. Brian has been consulting to a wide range of medical device companies on regulatory compliance, with specific interest in Software as a Medical Device SaMD. Consulting customers include MD Compliance and Emergo (and their customers), BrightInsight, Amgen, and South African companies. Brian compiles Technical Files for CE marking, writes Clinical Evaluation Reports (CER), and compiles FDA 510(k) submissions. Brian is also active in IEC standards development.Specialties: SaMDMDR / IVDRMedical devices regulatory expertiseSoftware lifecycle development management