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