Certifications

ISO13485

CSMi holds both and ISO 13485-2016/MDSAP and EN ISO 13485-2016 registrations.

ISO13485

  • 200090H CSMi ISO 13485-2016/MDSAP Certificate of Registration
  • 200402A CSMi EN ISO 13485-2016 Certificate of Registration
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    EC Certificate

    EC Certificate

  • 200091D HUMAC NORM Intertek EC Certificate.
  • T101-2-3-MED-MDR MDD Extension Confirmation through Dec 31, 2028.
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    HUMAC NORM and TMC Declaration of Conformity

    HUMAC NORM and TMC Declaration of Conformity

  • 200165O HUMAC NORM Declaration of Conformity.
  • 200093L TMC Declaration of Conformity.
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    Medical Devices Regulation (MDR) in the EU

  • We have completed our Stage 1 MDR audit.
  • Our Stage 2 audit is scheduled for later this year.
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