MCD recognises the importance of a stringent quality management system to ensure the highest standard of products are delivered to the market. We are ISO 13485 certified, which integrates strict design control from the beginning of assay development, through transfer to production, product validation and finally launch.

Our staff are also experienced in FDA 510(k) premarket notification applications and we maintain all documentation to enable our collaborators to obtain CE marking or FDA clearance.

A copy of our ISO 13845 Certificate is available to download here:

MD 636500.pdf