Quality Policy

ISO 13485:2012 Accredited Quality System
CREAGH MEDICAL is committed to provide quality medical devices that improve patient care, meet regulatory and customer requirements through an effective Quality Management System.
Established Compliance to:

  • ISO13485:2012
  • European Medical Device Directives 93/42/EEC
  • Canadian Medical Device Regulations MDR SOR/98-282
  • Japanese MHLW Ordinance No 169, 2004
  • FDA Quality System Regulation 21 CFR Part 820

Features of our Quality System

  • A rigorous internal auditing program.
  • An established corrective and preventative action system.
  • An extensive document control system
  • Regulatory capability for
  • –        CE marking for Class IIa devices
  • –        Traditional 510k and Special 510k submissions for Class II devices
  • –        Mutual Recognition process for Australia Class III

FDA Registration number: 3005994106