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    Certified Management Systems

    • Management Systems

      EN ISO 13485 and MDD Annex II excl. 4

    • Certificate Holder

      Telemedical Innovations Sp. z o.o.

    • Test Mark Number


    The certificate holder's Management System corresponds to standard EN ISO 13485:2016.

    Certificate scopes

    • EN ISO 13485

      Design and development, manufacture and distribution of ECG signal recorders with dedicated software and equipment.

    • MDD Annex II excl. 4

      - CARDIOVICE ECG Recorder
      - CARDIOVICE App

    Certificates for these Management Systems


    Contact to the certificate holder

    Telemedical Innovations Sp. z o.o.

    ul. Wincentego Pola 16
    44-100 Gliwice