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 already taking steps towards compliance, ready for the updated implementation timeline of May 2025 for Class C products.
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.