Mologic strives to achieve excellence.

We want to supply the highest quality diagnostic products and services, which not only comply with all applicable regulations, but meet and exceed our customer expectations.

We aim to achieve this through rigorous implementation of our evolving Quality Management System, which meets the international standards:

ISO 13485 – the international standard for quality management systems for the medical device industry

ISO 9001 – the international standard for quality management systems for effective business organisations

Mologic’s quality system also meets Canadian government requirements (CMDCAS, Canadian Medical Devices Conformity Assessment System).

These are our certificates:

Canadian Medical Device CMDCAS Certificate issued by BSI Group America Inc. 
FM 674347, Effective 21 Jul 2017. Expiry 24 Sep 2018
Certificate of Registration, QMS – ISO 13485:2003Scope: The design, development and manufacture of IVD medical used in the detection of infectious disease status, inflammatory biomarkers and hCG including home use and near patient/point of care in vitro diagnostic devices.

EC Certificate – Full Quality Assurance. IVD Directive 98/79/EC, Annex IV, excl Sections 4 & 6. 
CE 654083. Issued 7 Feb 2017. Expiry 6 Feb 2022.
In respect of: Development and manufacture of self-test in vitro diagnostic devices for the detection of markers of infectious and inflammatory disease status, as an aid to diagnosis, using immunochromatographic (e.g. lateral flow strip) technology.

ISO 13485 QMS Certificate of Registration. ISO 13485:2003 & EN ISO 13485:2012.
MD 654079. Effective 5 Sep 2016. Expiry 24 Sep 2018
Scope: Design, development and manufacture of professional and self-test immunodiagnostic IVD devices for the detection of infectious disease, inflammatory biomarkers and human Chorionic Gonadotropin (hCG).

ISO 9001 QMS Certificate of Registration. ISO 9001:2008
FM 655860. Effective 26 Sep 2016. Expiry 14 Sep 2018
Scope: Design, development, manufacture and sale of in vitro diagnostic medical devices.

If you have any queries regarding Mologic’s quality procedures please contact:

John Wilkins.

E Mail: john.wilkins@mologic.co.uk


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