Abingdon Health is committed to manufacturing high-quality, reliable rapid tests through adherence to recognised quality standards and regulatory frameworks.
Quality is fundamental to everything we do at Abingdon Health. Our Quality Management System is managed by an in-house QARA team and regularly audited by independent accreditation bodies.
We maintain certifications across all three divisions and all group companies, ensuring that every product we develop, test, manufacture or provide regulatory consultancy for, meets the highest standards required for in vitro diagnostics and medical devices.
Certifications
Policies and certificates
View or download the quality policies and certificates held by Abingdon Health group companies.
Abingdon Health’s mission is to improve life by making rapid tests accessible to all. Abingdon’s core proposition is the provision of technology-enabled lateral flow contract services to customers across a wide range of industries. Our contract services include lateral flow development, lateral flow manufacturing and related services such as regulatory and commercial support. We also develop and commercialise our own lateral flow tests primarily under the Pocket Diagnostic (b2b) and Abingdon Simply Test (b2c) brands. We are committed to providing our customers with products and services that meet or exceed their expectations for safety, quality and reliability.
Quality Policy
Our values provide a framework that supports decision-making across our business and are as follows:
we want to enrich the lives of our team, clients and customers
we are committed to innovation and collaboration; now and always
giving our experts the freedom and confidence to put their best foot forwards
believing fervently in the difference our work can make in the World
Quality Policy
Our commitment to Quality underpins all aspects of our business processes, as well as being one of the key building blocks of the company alongside ‘Customer’, ‘People’ and ‘Collaboration’. We achieve this by:
Our dedicated QARA team oversees compliance across the group, providing in-house regulatory expertise for CE/UKCA marking, IVDR transition, FDA submissions and international market access.
Abingdon Health maintains its Quality Management System through a process of continual improvement supported by quarterly reviews to ensure the highest standards of Quality management are maintained.
A full signed copy of our Quality Policy (QMP212) is available on request. For further information relating to our quality standards please contact our QARA team at +44 (0) 1904 406050 or info@abingdonhealth.com.
Our QARA team can advise on quality systems, regulatory strategy and compliance requirements for your diagnostic product.