Quality standards and accreditations

Abingdon Health is committed to manufacturing high-quality, reliable rapid tests through adherence to recognised quality standards and regulatory frameworks.

Abingdon Health production facility
Quality commitment

Built on certified quality systems

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.

Our quality policy is built on four pillars: People Focused, Progressive, Empowering and Passionate. We commit to complying with all relevant regulations, measuring business process effectiveness, ensuring personnel awareness of quality responsibilities and demonstrating leadership commitment.

ISO 13485 Medical device QMS
ISO 9001 Quality management system
UKAS ISO/IEC 17025 Accredited laboratory
FDA Registered establishment

Certifications

Our standards and accreditations

ISO 13485:2016
Quality management system for medical device design and manufacture
ISO 9001:2015
Structured approach to quality management meeting customer and stakeholder needs
IVDD 98/79/EC
EU In Vitro Diagnostic Directive compliance
IVDR 2017/746
EU In Vitro Diagnostic Regulation compliance
FDA 21 CFR 820
US Good Manufacturing Practice for medical devices
FDA 21 CFR 829
US FDA regulatory compliance
MHRA
UK medical device establishment registration
FDA
US medical device establishment registration

Quality assurance and regulatory affairs

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.

For quality or regulatory enquiries, please contact our QARA team on +44 (0) 1904 406050.

Need regulatory or quality support?

Our QARA team can advise on quality systems, regulatory strategy and compliance requirements for your diagnostic product.