From start-up companies with a novel medical product and who didn't know the first thing about compliance, to the Notified Bodies/Registrars, to national and regional organisations including ASQ and RAPS, The CRO Group has a long history of providing down-to-earth, easy to apply training in 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.

CRO Group training programs include general tutorials addressing entire regulations and standards, to seminars tailored to your company's specific situation. We have also prepared and conducted numerous courses for AAMI, ASQ, and RAPS.

Notified Body/Registrar Training

We offer training 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 in software/automated system validation.

Software Manufacturers

We offer related services to support European Notified Bodies, CMDCAS recognised registrars, as well as organisations and registrars intending to become Notified Bodies and CMDCAS registrars.