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  • ISO 13485 Certification

    ISO 13485 Certification

    Organizations involved in the life-cycle of a medical device

ISO 13485 Certification

ISO 13485The ISO 13485 standard concerns producers and suppliers of medical devices.

A certificate issued by an independent, accredited certification body guarantees that Quality Management Systems have been implemented, documented, used, maintained and improved by the supplier or producer of medical devices.

Benefits of 13485 certification:

  • guarantees high quality of provided services and products
  • reduces production loss rate
  • reduces operational costs
  • increases effectiveness across the whole organisation
  • increases your customers‘ trust in you as a safe supplier or producer

Certified organisations can include URS and UKAS logos in their promotional activities.

 Download a leaflet in PDF