Quality

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 complies with ISO 13485

 

MOLOGIC’S QMS CERTIFICATES:

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. Issued by BSI Assurance UK Ltd.
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.

 

MDSAP Certificate of Registration. Quality Management System – ISO 13485:2016 for Australia, Canada & USA.

Certificate MDSAP 676231. Effective date 6 Dec 2018. Expiry date: 24 Sep 2021. Issued by BSI Group America Inc, an MDSAP authorised auditing organisation.

Statement of Conformity: The company listed on this certificate has been audited to and found to conform with the following criteria: ISO 13485:2016 and Australia – Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) -Full Quality Assurance Procedure [if design controls are part of the certification]; Canada – Medical Devices Regulations -Part 1-SOR 98/282; USA – 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D:

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).

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

John Wilkins, Quality & Regulatory Affairs Manager.

E Mail: john.wilkins@mologic.co.uk

Lab statistics

image for Peptides synthesised
Peptides synthesised

10

this year to-date

image for Hours in the lab
Hours in the lab

67500

so far this year

image for Problems solved
Problems solved

79

this year

image for Assays completed
Assays completed

2700

this month

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