Nearmedic Plus production of diagnostic reagent kits passed international certification
Nearmedic Plus, the Russian producer of pharmaceuticals, medical equipment and diagnostic kits, has passed the international certification of its production of diagnostic reagent kits and received certificates of conformity of manufacturing and distribution of IVD reagents for detecting infection diseases such as HIV, tuberculosis, hepatitis, syphilis to the requirements of ISO 9001:2008 and ISO 13485:2003.
The certification was performed by SGS. SGS - the world’s leading inspection, verification, testing and certification company The issued certificates are recognized in the EC, USA, Canada, Australia and other countries and confirm the implementation and compliance with the highest standards of medical products quality.
"For the Russian pharmaceutical, biotech and medical companies such certification is still rare case, unfortunately” - said Prof. Anatoly Suslov, deputy general director of Nearmedic Plus. – “The compliance with international standards and good manufacturing practice guarantees the quality for Russian consumers, makes domestic companies competitive and opens the opportunities for export supplies”.
Nearmedic Plus LLC is the Russian pharmaceutical, biotechnology and medical company founded in 1989 at the Gamaleya Research Institute for Epidemiology and Microbiology of the Russian Academy of Medical Sciences.
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.