We are committed to meeting the highest standards in the industry using ISO 13485 driven quality systems. This is a comprehensive quality management system covering the development, manufacturing, sales, and distribution of In Vitro Testing components.
Our quality management systems are ISO 13485:2016 certified and we comply with Title 21 of the FDA CFR, part 820.
EU IVDR is ever on our radar, and we are taking steps towards compliance with the latest transitional implementation timeline of May 2026 for Class C products. In the meantime, all of our current product line complies with the requirements of the IVD Directive (IVDD).
Partnering with us means you will receive high-quality product and expert support from our team. We’re always here for you and are able to provide expert advice and support on an on-going basis. Our products are provided with everything you need: documentation, instructions and bespoke packaging as standard.
We are BS EN ISO 13485:2016 certified for the development, manufacturing, sale and distribution, including sub-contract manufacture, of in vitro diagnostic reagents and the supply of own-brand labelled equipment, distribution of related test equipment, and servicing of equipment.
All products are assessed against REACH (EC) No. 1907/2006 and CLP Regulation (EC) No. 1272/2008, and the majority do not require hazard labelling, risk and safety phrases or a Safety Data Sheet. It is company policy to use hazardous materials only if there is no alternative non-hazardous material available.
Due to products being manufactured in such a way as to reduce the amount of hazardous chemicals used as much as possible, the only product(s) classified as hazardous and therefore requiring a Safety Data Sheet are Acetylsalicylic Acid 30mg/ml, Acetylsalicylic Acid MEA and Imidazole Buffer Solution used within the ULTRASENSE Fibrinogen Assay Kit and The Fiix Test Kit. Their SDS' are available for download below:
