The CRO Group is a leading global consulting organization and service provider specializing 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, MDSAP, ISO 14971, IEC 62304, and other clinical, quality, and regulatory services.
With expertise in auditing, training, design development consulting, and more, The CRO Group offers customized solutions to accelerate product development and expand businesses worldwide, serving as trusted consultants and advisors for compliance and approvals since 1996.
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