The CRO Group is a leading global consulting organization and service provider. We specialize in providing consulting services for Medical Device, Biotechnology, In-Vitro Diagnostic, Over The Counter (OTC), Software as a Medical Device (SaMD), and mHealth product companies seeking FDA Approval/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.
The CRO Group conducts internal audits, supplier audits, and mock FDA inspections and Notified Body audits for regulated industry clients. We also conduct due diligence audits for both pre-acquisition as well as VC/Angel review of potential investments. We perform ISO 13485:2016 and MDSAP pre-audits as well as QSR with Design Controls readiness audits for SaMD (Software as a Medical Device) product companies especially prior to FDA device listing and establishment registration.
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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 custom training programs for regulated industries run the spectrum from short seminars on a specific requirement to day-long courses on the soon to be imposed EU Medical Device Regulations, ISO 13485:2016, ISO 14971, IEC 62304 (integrating Agile/SCRUM development) as well as MDSAP or FDA QSR including Design Controls as applied to SaMD and or other medical device products with software. Interested in one of these or a related regulation or standard?
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