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Quality & Regulatory

Quality & Regulatory

The development, manufacture and provision of our products and services meet the very highest standards of quality.

Deltex Medical is committed to fulfilling the requirements of: ISO 13485, US FDA Code of Federal Regulations 21 CFR Part 820, Medical Devices Directive 93/42/EEC (as amended) and the Canadian Medical Device Regulations P.C.1998-783 May, 1998. This commitment is demonstrated by maintaining a quality management system that is registered by, and subject to, independent assessment by the appropriate and recognised third party certification bodies.

  • ISO 13485:2003 Certificate of Registration
  • ISO 13485:2003 Certificate of Registration (CMDCAS Recognised for Canada)
  • Full Quality Assurance Certificate (93/42/EEC)
  • WEEE Membership Certificate

For further information regarding Quality and Regulatory related to our products please email the team: Q&R