TRUPCR Europe Ltd, a UK based supplier of molecular diagnostic qPCR and extraction kits, announces the successful completion of its ISO 13485:2016 BSI audit and certification of its Quality Management System. BSI is among the largest, most reputable, and experienced management systems certification bodies in the world, with more than 35,500 registrations worldwide.
ISO 13485:2016 is the industry standard for quality management systems regulating medical devices and related services that ensures the quality of a product’s design, development, and production consistently meet customer and applicable regulatory requirements. The International Organization for Standardization (ISO) is an international nongovernmental organization that publishes and governs a wide range of standards to ensure the safe, reliable, and quality production of products.
The certification allows TRUPCR Europe to manufacture its range of TRUPCR kits in its recently refurbished state-of-the-art facility based in Manchester, UK. The manufacture of kits will allow the company to offer a higher level of customer support in delivering and stocking kits.
This significant milestone is in line with the company’s vision of becoming a leading supplier of molecular diagnostic kits in Europe. The TRUPCR kit range allows efficiencies in laboratory diagnostics, ultimately resulting in better patient care and treatment.
Harminder Singh, CEO of TRUPCR Europe stated ‘I am delighted to have received the certification. The ISO13485:2016 recognises the company’s quality management system in ensuring our high performing kits are manufactured consistently. The company is committed to maintaining and delivering quality for our customers.’
About TRUPCR Europe
TRUPCR Europe is a leading molecular diagnostics company, with a portfolio of over 100 CE-IVD qPCR kits targeted at Oncology, Infectious Disease, AMR, Human Genetics and a range of complementary nucleic acid purification kits. The qPCR kits have been validated on multiple Real-time PCR instruments and include all the reagents and controls to run the assay. The highly sensitive, robust, and easy-to-use TRUPCR kits offer one of the most comprehensive range of kits on the market.