ISO 13485

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

A certificate issued by an independent, accredited certification body guarantees that a quality management system has 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

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If you are interested in this certificate, do not hesitate to contact us through the Enquiry Form.

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Why Choose URS Certification?

  • URS Certification is a holder of the international accreditation UKAS - United Kingdom Accreditation Service.
  • More than 40,000 contracts from 32 countries have attested to the high quality of URS Holdings services.
URS Holdings Worldwide
Over 47 000 contracts
in 40 countries!
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URS Certification (M) Sdn. Bhd.
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No. 7 Persiaran Sukan, Seksyen 13 40100 Shah Alam
Selangor Darul Ehsan, Malaysia

T: 603-5511 8636
E: ursmcert@ursmalaysia.com

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