Predictive diagnostics company Proteomics International Laboratories (ASX:PIQ) has successfully retained its ISO 13485 certification, an internationally recognised standard for safety and quality management systems in the manufacture of medical devices.
The company said recertification will benefit future global sales of the PromarkerD test for diabetic kidney disease and its robust pipeline of innovative diagnostic tests under development.
ISO 13485 certification ensures patient safety is the priority, with its primary purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. It represents a stringent commitment to quality and safety standards in the production of diagnostics tests and has been adopted globally.
Proteomics International managing director Dr Richard Lipscombe said recertification is a significant achievement. “Achieving recertification for another three years demonstrates Proteomics International’s commitment to delivering high-quality products, as well as the Company’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements,” he said.
