We offer consulting, auditing and training services for medical device, biotechnology, and IVD companies to comply with FDA-QSR, ISO 13485, Canadian MDR (CMDCAS), and EU MDD or IVDD regulations, and Part 11 regulation.
We offer related staff and services to support European Notified Bodies and CMDCAS recognised registrars.
We offer consulting services for software companies that wish to "break in" to the regulated industry market with related applications - for auditing, defect analysis, ERP/MRP, document control, etc.