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Abingdon Health ISO 13845 certification for lateral flow manufacturing

Lateral Flow Manufacturing Quality Standards

Whether Abingdon Health is developing a lateral flow test for our product line or for a commercial partner we will follow a process of design, development, testing, validation, and approval under a new product development plan.

Abingdon Health’s manufacturing facilities are GMP compliant, with the U.S. Food and Drug Administration (FDA), for the design, development, and manufacture of lateral flow devices, and device readers for in vitro diagnostic medical use.Abingdon Health LFIA manufacturing: ISO 13485 certified and GMP compliant

Abingdon Health has ISO 13485:2003 (including EN ISO 13485:2012) & ISO 9001:2008 certification for the development and manufacture of lateral flow immunoassay diagnostic devices and readers.

Regulatory approval

When developing and manufacturing lateral flow devices for regulated markets Abingdon Health follows a regulatory approach plan. The plan outlines the intended use for the product whilst providing evidence of the development process, including identifying regulatory requirements applying to the product and end user market/country. Having such a plan makes sure the approach to assay development and manufacture, and assay performance, for our own products or our contract customers, follows the correct regulatory path.

The regulatory process can be complicated and it requires a great deal of expertise to complete, as design history files will require completing along with pre-market notifications, risk management and technical file declarations of conformity.

All Abingdon Health staff members are trained in quality management, and take an active role in process evolution to maintain standards.

Good Manufacturing Practice (GMP) – GMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

ISO 13485:2003 – specifies requirements that our quality management systems demonstrate the ability to provide medical devices which consistently meet regulatory requirements applicable to medical devices.

ISO 9001:2008 – specifies requirements that our quality management systems demonstrate the ability to consistently provide products which meet customers and applicable statutory and regulatory requirements.

For further information relating to our lateral flow manufacturing quality standards please contact us on+44 (0) 1904 406080 or