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Röchling Medical Quality Systems
  • Medical
  • Quality Systems
  • Certifications
  • Certifications

    Thanks to our consistent application of our quality management system certified to pharmaceutical requirements, which is closely linked to compliance with good manufacturing practice (GMP) guidelines, we guarantee that processes occur under controlled and reproducible conditions at all times.

    Röchling Medical has a large number of certifications related to everything from quality management to environmental safety to specific products, and is constantly working on new developments and corresponding certifications.

    Everything we do is marked by a strong sense of environmental and energy consciousness, which is reflected in our implementation of certified management systems in accordance with ISO-14001-Environment and ISO 50001-Energy.

    Manufacturing products for the pharmaceuticals, life sciences and diagnostics industry entails strict standards, which regards environmental conditions. That is why our production takes place in a controlled environment.

    The following table shows an overview of the certifications our individual locations hold: 

    CertificationAreaNeuhaus
    Germany
    Brensbach
    Germany
    Rochester
    USA
    Lancaster
    USA
    Waldachtal
    Germany
    Suzhou
    China
    ISO 9001Quality Management SystemXXXX
    ISO 15378GMPXX
    ISO 13485Medical DevicesXXXXXX
    ISO 16949Design & Development Management Sytsem
    ISO 50001EnergyXXX
    ISO 14001EnvironmentXX
    ISO 8317Child Resistant PackagingX
    Drug Master Files(for selected products)X
    IATF 16949 XX
    FDA Registered 30013973202531321

     

    Documents: Certifications and Approvals

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    Kontakperson
    Joachim Lehmann
    Director BU Medical Europe
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