The CRO Group is a leading global consulting organization and service provider. We specialize in providing consulting services for Medical Device, In-Vitro Diagnostic, Over The Counter (OTC), Digital Health, Software as a Medical Device (SaMD), and Wearable product companies seeking FDA Approval/de Novo/Clearance, CE Marking, Clinical Studies, ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, as well as other Clinical, Quality, and Regulatory services. We are also registered with FDA as an U.S. Agent. We value our clientsâ€™ business and provide worldwide services.