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 as well as EU IVDR.
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 product(s) 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 our policy to use hazardous materials only if there is no alternative non-hazardous material available.
Due to our efforts to manufacture products in a fashion to reduce the amount of hazardous chemicals used, only two of our products (acetylsalicylic acid [aspirin] 30mg/ml & imidazole buffer solution) have been assessed and classified as hazardous. You can download their safety data sheets below.