The ISO 13485 standard defines the requirements for quality management in the manufacture of diagnostic products and medical devices
Avacta Group, a developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, has announced its Life Sciences’ diagnostics division has achieved ISO 13485 certification. The certification relates to the diagnostics division’s quality management system for the manufacture and distribution of Affimer reagents for use in lateral flow, ELISA and immunodiagnostic in-vitro diagnostic devices.
The ISO 13485 standard defines the requirements for quality management in the manufacture of diagnostic products and medical devices. The certification follows the company passing an audit by the Avacta’s Notified Body (BSI Group) of the company’s quality management system in April 2021.
ISO 13485 certification means 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 legal manufacturer of all future in-vitro diagnostic products.
Dr Alastair Smith, CEO of Avacta Group, said: “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.
“ISO 13485 certification is recognised globally by our partners, customers and regulatory bodies alike as the medical device industry benchmark for quality. This certification marks a major milestone for Avacta and underpins the product development strategy for the future of our diagnostics division.”