Our Expertise

The CRO Group is a leading global consulting organization and service provider. We specialize in Medical Device, In-Vitro Diagnostic, Over The Counter (OTC), Software as a Medical Device (SaMD)/Digital Health, and Wearable product companies seeking FDA Clearance/Approval, CE Marking, Clinical Studies, Quality, Risk, as well as other Regulatory Management services. We are also registered with FDA as an U.S. Agent. We value our clients and provide worldwide services.

CRO stands for “Contract Regulatory Organization.” We work with regulated industries including the developers and manufacturers of medical devices and In Vitro Diagnostics (IVDs). Our specialties include cost effective ISO 13485/MDSAP, and FDA QSr (Quality System regulation) compliant Quality Systems. We also prepare a variety of submissions including 510(k)s, 513(g)s, technical files, clinical study protocols, and IDEs.

ABOUT OUR CLIENTS:

The CRO Group works with companies large and small, with as few as two employees, and with multiple divisions and staffs in the thousands. Most of our clients are smaller in size, need high quality regulatory services, and found it impossible to afford a salaried quality/regulatory professional that meets all their needs.