Mission StatementOur vision is for Diagnostic Reagents Limited to be the most highly valued provider of In vitro diagnostics (IVDs) by the customers we serve globally, to maintain a high quality, fair price and excellent customer service; whilst promoting growth and stability from within.
Quality PolicyDiagnostic Reagents Limited (Diagen), aims to be a successful, profitable and customer driven organisation in the manufacture of IVDs. The organization hopes to accomplish this goal by:
Quality Management System and Medical Device Regulation (MDR)
Diagnostic Reagents Limited have a Quality Management System (QMS) that conforms to BS EN ISO13485:2016, the international standard for Medical Device manufacturers. We are currently compliant with the applicable IVD Directive 98/79EC and are in the process of implementing the new regulation IVDR 2017/746 in time for the deadline in May 2022. In the near future, due to the UK leaving the European Union, the UKCA mark will also be required for products to be sold within the United Kingdom, our customers can be confident that we will comply with its requirements and no disruption to supply will occur.