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.

Our consultants don't just audit, we provide value-added auditing services, assisting management in not only achieving conformity, but doing so without "breaking the bank."

Regulated Industries Consulting

We offer 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.

Notified Body/Registrar Auditing

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

Software Manufacturer Auditing

We offer auditing services for software manufacturers that wish to "break in" to the regulated industry market with related applications including that for auditing, defect analysis, ERP/MRP, document control, etc.