About the enterprise
Quality is the main strategy!
Production unitary enterprise "FreBor" was established in 1991 as Belarusian-German joint venture Fresenius-Borisov-Dializotechnik Ltd (JV "FreBor" Ltd). Production capacities based on unique FMC technologies and designed to produce 2 million dialyzers and 2 million sets of blood lines a year were commissioned in May 1992. Production of universal medical transfusion-infusion set UMS and other import-substituting products, which production now fully covers the needs of the Health Care of the Republic of Belarus was started in 1993. Two manufacturing lines for polysulfone fibers of main filter element of capillary dialyzer were started up in 1994 and 1997.
Quality of our products is a fundamental requirement for the production cycle. The Quality Management System (QMS) that meets the requirements of ISO 9002:1994 and EN 46002:1993 (ISO 13488:1996 later on) was implemented and has been applied in the company since 1995. For the implementation in 2001 of the high-quality methods of management and for the production of the competitive products, the company was awarded with the Prize of the Government of the Republic of Belarus. The Prize of the Government of the Republic of Belarus was given once again in 2004 and 2007.
The company management pays special attention to environment protection. The environmental certificate № BY/112 05.1.0.TSA0004 of 15.04.2003 for compliance with requirements of STB ISO 14001-2000 was issued by the National certification system of the Republic of Belarus . In the year 2003, the company has implemented and Certified Environmental Management System (EMS).
The company is on the way to further development of management system. The Integrated Management System that combines Quality Management System and Environmental Management System was implemented on the Production unitary enterprise "FreBor" since 01.01.2004. The Integrated Management System is based on the requirements of the international standards ISO 9001:2000, ISO 13485:2012/AC:2012, ISO 14001:2005, GMP-Norms, the Council Directives (93/42/EEC) of 14.06.1993.
Clinical evaluation of manufactured by our enterprise medical devices is annually carried out by qualified medical professionals of our country in compliance with the requirements of Medical Devices Directives «Clinical evaluation: A Guide For Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC» MED-DEV 2.7.1