Quality Assurance

ISO 13485 Certified design control and manufacturing is applied to all projects.

MC Diagnostics is ISO 13485 Certified

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:


why choose us?


MC Diagnostics is a specialist molecular diagnostics company with expertise in the automation of multiplexed molecular assays and custom designed image analysis and interpretation software. Read more about our capabilities below ...

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+44 (0) 1745 535225

 Address Location

MC Diagnostics Ltd
Unit 5 OpTIC
Ffordd William Morgan
St. Asaph Business Park
United Kingdom

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