Quality and Certification

Caltag Medsystems is not your typical distributor. We are also a manufacturer of a flow cytometry reagent, our cellular antigen stabilisation reagent TransFix®, which is sold through our sister company Cytomark. Our Cells Division provides cell expansion services as well as quality human primary cells and growth media. As such, we are accredited to ISO13485 and are committed to produce only the highest quality products.

If you have IVD registered products to sell in the UK we can help. We have a detailed understanding of the regulations with our own IVD products registered worldwide.

ISO13485 Certification

ISO 13485:2016

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

Globally recognised, the ISO 13485 standard defines the quality management system requirements for 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".

Caltag Medsystems, under the Cytomark brand, already manufactures a number of products for the medical sector. Maintaining the ISO 13485 certification demonstrates that our quality credentials have been proven through independent verification.

Caltag Medsystems works in partnership with a small number of carefully selected tissue procurement organisations in sourcing human tissue and cells. We are committed to operating under the highest ethical and legal standards in the procurement of human and animal tissues from these suppliers.

The Human Tissue Authority has licenced Caltag to procure, process and store human tissue in the UK. You can be assured the human and animal material purchased from us has been ethically sourced as we will not obtain tissue from a supplier unless they can show the correct ethical information.

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