Avacta’s Diagnostic Division Achieves ISO 13485 Certification
The ISO 13485 standard defines the comprehensive requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices.
- The ISO 13485 standard defines the comprehensive requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices.
- 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 Avactas diagnostics division has achieved ISO 13485 certification.
- ISO 13485 certification is recognised globally by our partners, customers and regulatory bodies alike as the medical device industry benchmark for quality.