Avacta Life Sciences’ diagnostics division has achieved ISO 13485 certification for the quality management system for the manufacture and distribution of Affimer reagents for lateral flow, ELISA and immunodiagnostic in vitro diagnostic devices.
The ISO 13485 standard defines the comprehensive requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices. The certification, which provides a practical foundation for Avacta to address the regulatory requirements and ensure the safety and quality of its products, follows after having successfully passed the audit by Avacta’s Notified Body (BSI Group) of the company’s quality management system in April 2021.
ISO 13485 certification means that the CE mark for the AffiDX SARS-CoV-2 antigen lateral-flow test can be transferred to Avacta from its partner, Mologic, and Avacta will be the legal manufacturer of all future in vitro diagnostic products.
Dr Alastair Smith (Chief Executive Officer of Avacta Group) commented: “We are delighted that Avacta’s diagnostics division has achieved ISO 13485 certification. The team have delivered excellent systems, processes and practices that now make up our quality framework, supporting the future growth and commercial success of the company.