Mologic strives to achieve excellence.

We strive to supply the highest quality diagnostic products and services, which not only comply with all applicable regulations, but meet and exceed our customers’ expectations. We achieve this through implementation of our Quality Management System, which has been updated to comply with ISO 13485:2016 Medical Devices – Quality management systems – Requirements for regulatory purposes.


Our QMS addresses the requirements of the Canadian Medical Device Regulations and we hold a Canadian Medical Devices Conformity Assessment System (CMDCAS) certificate.


Mologic’s QMS was audited by BSI in July-September 2018 against the requirements of the Medical Device Single Audit Programme (MDSAP) for Australia, Canada and the United States of America. We await confirmation of the recommendation for certification.

Details of our QMS certificates from BSI:


Certificate of Registration. Quality Management System – ISO 13485:2016 & EN ISO 13485:2016

Certificate Number MD 654079. Effective 25 Sep 2018. Expiry 24 Sep 2021. Issued by BSI Assurance UK Ltd.
Scope: Design, development and manufacture of professional and self-test immunodiagnostic (lateral flow) IVD devices for the detection of infectious disease, inflammatory biomarkers and human Chorionic Gonadotropin (hCG).


Certificate of Registration. Quality Management System – ISO 13485:2016
Canadian Medical Device Conformity Assessment Scheme (CMDCAS).

Certificate Number FM 674347. Effective 21 Sep 2018. Expiry 31 Dec 2018. Issued by BSI Group America Inc. (CMDCAS recognised registrar).
Scope: The design, development and manufacture of IVD medical devices 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
Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex IV, excluding Sections 4 and 6.

Certificate Number 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.

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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