ROBOSCREEN is certified for the introduction and application of a quality management system in accordance with Annex IX, Chapter I and III of Regulation (EU) 2017/746.
Roboscreen is certified according to DIN EN ISO 13485 for development, manufacture and distribution of molecular biological and immunochemical in vitro diagnostics.
EU Quality Management System Certificate according to Regulation (EU) 2017/746
Quality Management System Certificate according to EN ISO 13485
Quality System Certificate for Hepatitis Kits- as amended by Regulation (EU) 2024/1860 - Notified Body Confirmation