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Audit and Training


 

The CRO Group offers auditing services to companies in the medical device, biotechnology, and IVD industries to comply with FDA-QSR, Part 11, ISO 13485, Canadian MDR (CMDCAS), and EU MDD or IVDD regulations, as well as related to clinical trials.

Our Consultants are accredited Notified Body/Registrar Lead Auditors , experienced in auditing to requirements of Quality Management Systems standards including ISO 13485 and ISO 9001, FDA Quality System Regulation, EU Medical Devices Directive (EUMDD) and In Vitro Diagnostics Directive (IVDD), Canadian Medical Device Regulation (CMDR/CMDCAS), 21 CFR 11/Electronic Signature/Electronic Records, and 21 CFR 812/Investigational Device Exemption as well as that of other related regulations.