Biocare Medical has achieved ISO 13485:2016 Certification as of February 20, 2019.

The quality management system is applicable to:

  • Design, manufacture and distribution of in vitro diagnostic (IVD), immunohistochemistry reagents/kits, and design, manufacture, distribution, installation and service of general purposes laboratory equipment medical devices.
  • Additional site1: Manufacture, installation and service
  • Additional site2: Design and manufacture

Download our ISO 13485:2016 Certificate of Registration Here.

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