Performance Evaluation for FDA 510(k): Building Your Substantial Equivalence Case
Together with 9 other partner organisations, Abingdon Health plc is developing a rapid serological diagnostic test to detect Plasmodium vivax hypnozoites, which will be critical for malaria disease control, especially in remote areas. Coordinated by Michael White, Inès Vigan-Womas and… Read More
A leading global animal health organisation has contracted Abingdon Health since 2019 for end-to-end CDMO solutions. The project focused on optimising, transferring, and scaling up manufacturing processes, delivering a high-quality, market-ready lateral flow diagnostic device for animal care. Following successful delivery, Abingdon Health was retained for routine manufacturing spanning multi-deal… Read More
US-based Find Out From Home LLC ("FindOut"), formerly known as MyMark and Devyn, is a US-based biotech company focused on providing accessible, user-friendly at-home diagnostic testing, empowering people to manage their health proactively through easy-to-use at-home health tests. In 2022, FOFH awarded Abingdon Health the contract for developing a range… Read More
Read the latest blog from Abingdon Health’s Quality & Regulatory Director, Candice Vendettuoli on the importance of managing your analytical performance and clinical evaluation together. Creating a robust technical file for medical devices requires mastering two fundamental pillars: analytical performance studies and clinical evaluation. These components work in… Read More
A leading US-based clinical testing authority specialising in human medical and veterinary diagnostic testing of fungal infections approached Abingdon Health to optimise, transfer and scale up the development of two new lateral flow tests (LFTs) in their suite of IVD test devices, over the course of a complex, multi-year project… Read More
Read the latest blog from Abingdon Analytical Director, Candice Vendettuoli, who will be attending the upcoming Clinical Innovations EXPO in Nottingham on 15 May 2025. In this blog Candice provides a detailed overview on analytical performance studies under IVDR, a key part of your regulatory plan, and outlines… Read More