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ISO 13485 Certification

Quality Management System

ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for medical device manufacturers and describes a process approach in terms of the design, safety and quality.

ISO 13485 Certification

  • ISO 13485 certification shows that an organisation has successfully met the requirements of this standard. In addition to facilitating supplier validation, this certification is increasingly considered to be the basis for market authorisations of medical devices, including CE and UKCA marking.
  • Evidences a manufacturer's commitment to quality by the objective assessment of products, processes and services.
  • Documents compliance according to the relevant standards for manufacturing of medical products.
  • Meets major industry requirements from legal manufacturer's through to component manufacturer's feeding into the pipeline.
  • Can be delivered in combination with other schemes such as MDSAP, CE marking and/or UKCA marking through DEKRA's one-stop approach to medical service delivery.

DEKRA’s audit team consists of experts with extensive skills and expertise to accurately assess the compliance of your management system according to ISO 13485.

Downloads

Contact

DEKRA Certification GmbH  (NB 0124)

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+49 711 7861 3771
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DEKRA Certification B.V. (NB 0344)

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+31 88 96 83009
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