sales@diagen.co.uk +44(0)1844 212426 Wenman Road, Thame, Oxfordshire, OX9 3NY, UK

Quality

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Mission Statement

Our 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 Policy

Diagnostic 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:

  • Meeting or exceeding customer expectations by tailoring our service and production to the customers needs.
  • Satisfying the requirements of the quality management system (BS EN ISO13485:2016), to maintain and develop growth and success.
  • Measuring and improving operational performance to give higher quality and reliability.
  • Complying with all regulatory and statutory requirements.

    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. Please click on the logo below to view and download our ISO certification.

    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.