CORK, Ireland April 19th, 2019. Metabolomic Diagnostics has today announced that its Quality Management system has successfully transitioned from ISO 13485: 2012 to ISO 13485:2016 following an audit by Certification Body, BQAI. This certification indicates that the company has implemented a quality management system that conforms to standards specific to medical devices, including in vitro diagnostic (IVD) assays.
“This is an important milestone for our company as it reflects our commitment to providing the highest quality of design and development of our products at Metabolomic Diagnostics” said Mr. Charles Garvey, CEO of Metabolomic Diagnostics. He added “Achieving this certification reflects our continuous efforts and improvements to ensure we deliver accurate, safe and reproducible products”.
As the company’s flagship product, PrePsiaTM , a risk predictor test for pre-term pre-eclampsia, nears market deployment, Metabolomic Diagnostics ongoing efforts to maintain the certification will ensure it meets the requirements of the FDA as outlined in 21 CFR 820, and the European Commission’s IVDR.
ISO 13485:2016 is the latest and most current version of ISO 13485. It is an internationally recognised quality standard for a quality management system to ensure customer and regulatory authorities’ requirements are consistently met for IVD products.