The CRO Group is a leading global consulting organization and service provider. 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 Studies, 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.
The CRO Group conducts internal audits, supplier audits, mock inspections and audits, and risk management audits on behalf of regulated industry clients. We also conduct due diligence audits for both pre-acquisition as well as VC/Angel review of potential investments. We perform information technology audits according to GAMP, Part 11 and clinical trial data requirements.
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The CRO Group provides consulting services acting as part of your engineering, clinical, quality and regulatory team.
Please find our recent technologies and techniques along with our recent devices that we have worked with below.
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The CRO Group training programs for regulated industries run the spectrum from short seminars on a specific requirement to day-long courses on the EU Medical Device or IVD Directives (including expected Recast changes), ISO 13485:2012, ISO 14971:2012, IEC 62304 (and using Agile/SCRUM) as well as Canadian Medical Device Regulation. Interested in one of these or a related regulation or standard?
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