14th April 2026
Imspex Diagnostics renews ISO 13485 certification, supporting advancement of next-generation diagnostic technologies
Imspex Diagnostics Ltd, headquartered in Abercynon, Wales, has successfully renewed its ISO 13485:2016 certification for medical device quality management systems, reinforcing its commitment to regulatory excellence and product reliability.
The certification renewal follows a comprehensive audit of the company’s design, development, and manufacturing operations, conducted at its UK headquarters and assessed by leading international certification body, Eurofins.
ISO 13485:2016 is a globally recognised standard that ensures organisations consistently meet both customer and regulatory requirements for medical device safety and performance. Maintaining this certification demonstrates Imspex’s continued adherence to rigorous quality processes across its operations.
This renewal provides a strong foundation for the company’s ongoing innovation pipeline, supporting the development of its next generation of fully connected, AI-enabled diagnostic instruments, devices and sensor-based systems. These advancements are being progressed within a robust quality and regulatory framework, enabling Imspex to accelerate innovation while maintaining compliance with international medical device standards.
Contact the Imspex Diagnostics team for more information:
John McKinley, Director and CEO – john@imspex.com
Amber Jacobs, PR & Marketing Manager – amber@imspex.com