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 clients’ business and provide worldwide services.
Auditing
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Training
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Design & Development Consulting
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We have the expertise to accelerate your product development
and expand your business worldwide
Try Us, You’ll Like Us
Take the guesswork out of your Development and Regulatory plans so you can get back to what’s really critical – running your business. We’ve been working with Medical Device and IVD clients since 1996 – serving as trusted consultants and advisors for compliance and approvals.