Leukocare Biotechnology AG


In order to comply with ISO standards, LEUKOCARE implemented a Quality Management System for its services in design, development, manufacture and distribution of technologies and products for biofunctional surface engineering and stabilization of biomolecules in the field of medical devices and diagnostics to ensure consistent and high quality. The certification according to ISO 13485 was first granted in 2009 and continuously re-certified since then. The transition to EN ISO 13485:2016 was performed in 2018.

You may obtain access to the certificate in PDF format by clicking on the figure ­below:

Certificate ISO 13485:2003 & EN ISO 13485:2012