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  • Certified Management Systems

    • Management Systems

      ISO 9001 and ISO/IEC 27001

    • Certificate Holder

      KCRI Sp. z o.o.

    • Test Mark Number

      9000020744

    The certificate holder's Management System corresponds to standards:

    1. ISO 9001:2015

    2. ISO/IEC 27001:2013

    Certificate scopes

    • ISO 9001

      Consultancy with respect to the selection of clinical trial centres as well as medical and regulatory issues and GCP. Planning, conducting and supervision of phase I/„First In Man”-IV clinical trials. Independent and standardized analyses of angiographic images, intravascular ultrasound and ECG.

    • ISO/IEC 27001

      Consultancy with respect to the selection of clinical trial centres as well as medical and regulatory issues and GCP. Planning, conducting and supervision of phase I/„First In Man”-IV clinical trials. Independent and standardized analyses of angiographic images, intravascular ultrasound and ECG. Declaration of use dated 17.06.2022 version 0.2

    Certificates for these Management Systems

    Contact to the certificate holder

    KCRI Sp. z o.o.

    ul. Wadowicka 7
    30-347 Kraków
    Poland