Audit and Training


 

The CRO Group offers auditing and training services to companies in the medical device, biotechnology, and IVD industries to comply with FDA-QSR, Part 11, ISO 13485, Canadian MDR (CMDCAS – soon to be replaced by MDSAP), EU MDD or IVDD regulations (as well as the soon to be implemented MDR and IVDR EU 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, soon to be replaced by MDSAP), 21 CFR 11/Electronic Signature/Electronic Records, and 21 CFR 812/Investigational Device Exemption as well as that of other related regulations.

Regulated Industries Auditing


From start-up companies with a novel medical product but novices about compliance, to the Notified Bodies/Registrars, to well established multi-division global manufacturers, since 1996, The CRO Group has providing down-to-earth, value added audits in Quality Management Systems standards including ISO 13485 and ISO 14971, FDA Quality System Regulation, EU Medical Devices Directive (EUMDD) and In Vitro Diagnostics Directive (IVDD), Canadian Medical Device Regulation (CMDR/CMDCAS – soon to be replaced by MDSAP), 21 CFR 11/Electronic Signature/Electronic Records, and 21 CFR 812/Investigational Device Exemption as well as that of other related regulations.

 

 “Our consultants don’t just audit, we provide value-added post-auditing services, assisting management in not only achieving conformity, but doing so swiftly and in line with your budget.” Glen Emelock, Sr. Partner

Regulated Industries Training


CRO Group training programs for regulated industries run the spectrum from a one or two hour seminar on a specific requirement to one or two days on the entire EU Medical Device or IVD Directive, the FDA Part 11 (21 CFR 11) Regulation, and or establishing an Internal Audit program addressing ISO 13485 and QSR, Canadian Medical Device Regulation, as well as the MDSAP scheme due to replace CMDCAS, and EU MDD or IVDD including the MDR and IVDR changes.

When you arrange a CRO Group training, you’re in good company.  CRO Group has conducted numerous training programs for RAPS, Advamed, ASQ, and AAMI.

We offer standards and regulation training programs including:

– ISO 13485                      – QSR                             – Internal Auditing

– EU MDD/IVDD             –  EU MDR and IVDR       – ISO 14971 / Risk Management

– IEC 62304                    – CMDR / MDSAP            – IEC 62304 with Agile/SCRUM