Cytomark recognises the importance of ensuring the correct quality and regulatory standards are applied to everything we do. We promise to deliver products and services that meet the highest of standards so you can rest assured your valuable time and resources are fully optimised.Cytomark Limited is a Division of Caltag Medsystems Limited that is certified to the ISO 13485:2016 standard. Globally recognised, the ISO 13485 standard defines the quality management system requirements for the manufacture of medical devices.We are experienced at working with regulators world-wide and have several CE IVD and FDA cleared products. For a full list of countries where our products have been licenced please click here. Contact us to enquire about getting Cytomark products licenced in your territory.
With the UK exiting the European Union we have engaged an EU Authorised Representative and invested in all the necessary regulatory changes to ensure a smooth transitional period for our customers in Europe.
