Matrix Cell Research Inc.’s Quality Management System (QMS) conforms with the international standard ISO13485, which specializes in the medical device industry and has been adopted as the base of quality control methods for medical devices worldwide.
QMS covers a wide range of processes – from design and development to purchasing, manufacturing, inspection, as well as post-shipment monitoring – and ensures products and services with a consistent quality, by adhering to the procedures established for each individual process.
In addition, QMS maintenance is conducted through regular management review and internal audit, and any quality control measures conducted in accordance with this QMS apply, even when products are manufactured by a Third Party Manufacturing Company.
The company’s EN ISO13485:2016-certified management system and CE Marking of Conformity obtained in July 2019 warrant the high quality of TAKUMI magnetic probe.