FUJIFILM Wako Chemicals Europe GmbH is known for its high quality chemicals and reagents. To maintain and even enhance the high quality level of our products, we have implemented an integrated quality management system based on the international quality standard ISO 9001:2015 which is supplemented by the additional requirements of medical devices defined in EN ISO 13485:2016.
Furthermore, we comply with the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5th April 2017 on in vitro diagnostic medical devices (IVDR), as well as the German Medical Device Law Implementation Act (MPDG, German only) and the Medical Devices User Reporting and Notification Ordinance (MPAMIV, German only).
We are committed to quality and safety and strive to provide our customers with reliable products and technical service which meet their needs and requirements.
Therefore, our quality management system is regularly assessed by an independent certification company. Our quality police requires us to continously develop and improve our processes to be able to react quickly to new requirements and regulations and to provide customers with state-of-the-art solutions.
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