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  • Certificate No. 60144560

    • Certificate Number
      SX 60144560
    • Certificate Holder
      DIGITHURST Bildverarbeitungssysteme
      GmbH & Co. KG
      Wasserrunzel 5
      91186 Büchenbach
    • Scope

      Design and development, manufacture, distribution, service
      and installation of software for radiology

    • Fulfilled Standards
      EN ISO 13485:2016
    • Certificate Type

      Quality Management System
      EN ISO13485 quality management standard for medical devices and related services

      The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

      Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

      The customer's quality management system is subject to regular monitoring.

      Certified customers may use the test mark in their communication.

      Further information on this service can be found here.