Company Profile About us HISTORY BIOSINTEX was founded in 2002 and has been the only local producer of sutures. By using raw materials from suppliers certified according to international quality standards we produce a wide range of types and sizes of sutures, in combinations with or without a needle. Technical and quality parameters are tested all along the production flow, and the level of our performances has been reached upon customer's request. We also consider that we offer an equitable cost effective medical solution. HUMAN INVESTMEN TWe are helped by people and we work to help people. We mainly address patients whose trust in the Romanian medical system we want to increase, because we consider this as the only means to reach a higher level of quality as regards health care services and satisfaction of all involved parties. We pay a special attention to the professional development of our employees in order to fulfill at high performance the very dynamic needs of medical and administrative staff acting in the health care field. As a long term objective we wish to build a valuable organization to provide both patients and doctors with performant solutions, the best from the point of view of safety, within a partnership based on mutual trust and openness to cooperation. INVESTMENT IN PRODUCTION The production unit is located in Snagov, in the neighborhood of Bucharest. Lying on 1,400 sqm of built area, including production plant, warehouses, and offices, the unit in Snagov uses last generation technology and the production area complies with SR EN ISO 14644-1:2002 international standard referring to clean rooms and associated controlled environments. According to this standard, production areas classify at ISO Class 8, and according to the American standard FDA-US 209 E, they classify under Class D – Clean rooms. A clean room is a production area controlled from the point of view of air filtering and ventilating system, which provides constant concentration of particles inside the clean rooms and reduces particle generation by keeping them inside and maintaining constant parameters such as air temperature, humidity, pressure, and purity. By this simple procedure we comply with the European regulations in force referring to medical device production.