Quality and Certification

At Caltag, we are committed to maintaining the highest standards of quality both in the products we source and those we manufacture.

ISO13485 Certification

Caltag Medsystems Ltd. are certified to the ISO 13485:2016 standard.

ISO 13485:2016

Globally recognised, the ISO 13485 standard defines the quality management system requirements for the manufacture of medical devices. For Caltag Medsystems, ISO 13485 certification incorporates the "manufacture and supply of cellular stabilisation reagents for research and in vitro diagnostic use".

Maintaining the ISO 13485 certification demonstrates that our quality credentials have been proven through independent verification.

HTA Licensed

As a distributor of human tissue and cells, our premises have been assessed and licensed by the Human Tissue Authority (HTA) (License Number 12672). This license allows us to procure, process and store human tissue in the UK. In turn, we only work with suppliers who provide correct ethical documentation, so customers can be guaranteed that any human material supplied by Caltag has been responsibly and legally sourced.

Quality Management System

Finally, our ISO13485-compliant Quality Management System is incorporated into all areas of our business, ensuring excellence is part of our day-to-day routines. By having a strong focus on customer needs, complying with regulations, risk management and product safety, Caltag is committed to sourcing products researchers can rely on.