Avacta gets ISO certification for Affirmer manufacture and distribution

The AIM-traded firm said the standard defined the requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices.

It said the certification, which would provide a “practical foundation” for Avacta to address the regulatory requirements and ensure the safety and quality of its products, followed the successfully-passed audit by BSI Group, its notified body, of its quality management system in April.

ISO 13485 certification meant that the CE-mark for the ‘AffiDX’ SARS-CoV-2 antigen lateral flow test for Covid-19 could be transferred to Avacta from its partner, Mologic, meaning the company would be the legal manufacturer of all future in-vitro diagnostic products.

“We are delighted that Avacta's diagnostics division has achieved ISO 13485 certification,” said chief executive officer Dr Alastair Smith.

“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.”

Dr Smith said ISO 13485 certification was recognised globally by Avacta’s partners, customers and regulatory bodies 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.”

At 0844 BST, shares in Avacta Group were up 3.32% at 140p.