Avacta’s Diagnostic Division Achieves ISO 13485 Certification
July 14 2021 - 3:16AM
Business Wire
Avacta Group plc (AIM: AVCT), the developer of diagnostics and
innovative cancer therapies based on its proprietary Affimer® and
pre|CISION™ platforms, is pleased to announce that Avacta Life
Sciences’ diagnostics division has achieved ISO 13485 certification
for the 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 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.”
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Zyme Communications (Trade and Regional Media) Katie
Odgaard Tel: +44 (0) 7787 502 947
katie.odgaard@zymecommunications.com
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