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  • Certificate No. 60140299

    • Certificate Number
      SX 60140299
    • Certificate Holder
      Roesys MedTec GmbH

      Dr.-Max-Ilgner-Str. 2
      32339 Espelkamp
      Germany
    • Scope

      Design and development, manufacture, distribution,
      installation and service of digital X-Ray systems

    • Fulfilled Standards
      EN ISO 13485:2016
    • Certificate Type
      QMS

      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.