Tuv print icon Print Page Tuv share icon Share Page Tuv contact mail icon Contact
Tuv check icon

Thank you for your message.
We will get back to you.

Contact TÜV Rheinland

Sorry. This action failed due to a technical error. Please try again later.

Please fill out all fields marked with *.

Please describe your request as exactly as possible.
We will answer as soon as possible.
  • Certificate No. 60143156

    • Certificate Number
      SX 60143156
    • Certificate Holder

      Meißner Str. 191
      01445 Radebeul
    • Scope

      Design and development, manufacture and distribution of
      bone implants, bone cements and bone substitute materials
      and their precursors and intermediates

    • 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.