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 the 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 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.
“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.”