Imspex proudly announces its successful renewal of annual registration to ISO 13485:2016 for Medical Devices – Quality Systems – Requirements for Regulatory Purposes. This achievement follows comprehensive audits of Imspex Diagnostics’ design, development, and manufacturing operations at its Abercynon headquarters in the UK. The recommendation for registration was provided by Eurofins, a prominent international certification body.

“We are dedicated to providing cutting-edge analytics services and medical device products of the highest quality, within the highest international standards for quality management for our customers and to be one of the first commercial companies in our diagnostic testing industry to achieve this certification status” reported Chief Executive Officer John McKinley, IMSPEX Diagnostics, in Abercynon, Wales.

Emma Brodrick, Technical Director of IMSPEX Diagnostics, adds: “The award has certified that all key aspects of our business operations, within specific procedures set in place for evaluation and improvement our company’s key processes, are ensuring that our customers continue to receive unparalleled products and services while keeping pace with on-time delivery standards”. Chief Executive Officer John McKinley, IMSPEX Diagnostics, in Abercynon, Wales: “We’re incredibly excited about what it means for our future as a company and to be one of the first in our industry, who have achieved this certification status; I am so proud of our entire staff for achieving this tremendous honour.”

ISO 13485:2016 is a globally recognized international standard specifically tailored to ensure quality management systems consistently adhere to customer and regulatory demands for the safety and efficacy of medical devices. Founded on quality management principles, ISO 13485 enhances organisational performance in meeting these crucial requirements.