Regulatory and Quality Assurance

CIVCO Regulation and QA

EU declarations of conformity

MDD (EC) certifications

  • Sterile Fiducial Marker Kit (PDF)
    For Fiducial markers intended to be placed into soft tissue or bone to establish a permanent and accurate internal reference system.
  • Fiducial Markers und Fiducial Markers Kits (PDF)
    Sterile Fiducial Marker Kits with absorbable sutures, spacers and couplers. Sterile fiducial markers for ensuring accurate target localization for tumors or organs which move in respect to external anatomy, and for precise localization for stereotactic and typical fractionated radiotherapy treatment.

ISO certifications

  • ISO 13485:2016 & EN ISO 13485:2016 (PDF)
    For the design, manufacture, distribution, installation and servicing of devices for patient positioning and radiation oncology devices (shielding, ion chambers and phantoms). Design, manufacture, distribution of sterile fiducial markers.
  • MDSAP (ISO 13485:2016) (PDF)
    Design, manufacture, distribution, installation and servicing of devices for patient positioning and radiation oncology devices (shielding, ion chambers and phantoms). Design, manufacture, distribution of sterile fiducial markers.