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ISO 13485 Certification

Quality Management System

ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) developed for medical device and medical device related companies It ensures an organization’s commitment to process approach in terms of the design, safety and quality of medical devices. It meets all industry requirements and is increasingly considered to be the basis for CE certification of medical devices.

ISO 13485 Certification

  • ISO 13485 certification helps by the objective assessment of products, processes and services.
  • It enables the documentation of compliance according to the relevant regulations for manufacturing of medical products. Furthermore, it meets all major industry requirements, even as a supplier to the medical products industry.
  • When a facility is due for a quality system audit, the ISO 13485 enables to combine the quality system requirements with the regulatory requirements.

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.



DEKRA Certification GmbH  (NB 0124)

+49 711 7861 3771

DEKRA Certification B.V. (NB 0344)

+31 88 96 83009
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