The CRO Group

Welcome to The CRO Group The CRO Group is a global consulting organization and service provider for the medical device industry. We specialize in Medical Device, Biotechnology, In-Vitro Diagnostic, Over The Counter (OTC), Software as a Medical Device (SaMD), and mHealth product companies seeking FDA Approval, CE Marking, Clinical Trial, Quality, Risk, as well as other Regulatory Management services. We are also registered with FDA as a U.S. Agent, and in Europe as an Authorised Representative. We value our clients and provide worldwide services. Our specialties include cost effective CE Marking and Quality System / ISO 13485/CMDCAS certification and registration programs, and FDA QSr (Quality System regulation) compliance programs, including the new Design Control Requirements. We also prepare a variety of submissions including 510(k)s, 513(g)s, technical files, PMAs, design dossiers, Canadian license applications, clinical study protocols, and IDEs. With partners and consultants in the USA, Canada and Europe, The CRO Group is uniquely qualified to handle virtually all your regulatory compliance and market access issues. Each partner and affiliate is qualified to handle general medical device and quality system issues such as labeling, risk management, and design and process validations. Then, for subspecialties such as clinical investigations, sterilization validations, dielectric withstand, or waste disposal, we rely on our partners and affiliates robust backgrounds with medical and pharmaceutical product manufacturers.