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, diagnostics, research products and biopharmaceuticals to ensure consistent and high quality. The certification according to ISO 9001 and ISO 13485 was first granted in 2009 and continuously re-certified since then. The most recent re-certification according to ISO 9001:2008 was performed in 2016. The transition to certification according to ISO 13485:2016 and EN ISO 13485:2016 was performed in 2018.
You may obtain access to the certificates in PDF format by clicking on the figures below: