U.S.A.
B. Braun Medical Inc. (B.Braun) acknowledges that, to be truly competitive in today’s market, it must have a quality system that governs all phases of business operations in order to guarantee its customers that they will consistently receive the quality products and service that they expect.
B.Braun has instituted a quality management system that complies with the requirements of EN ISO 13485:2003/AC:2009, 21 CFR Parts 820, 210, 211, the Medical Device Directives 93/42/EEC and 2007/47/EC (MDD), and the Canadian Medical Device Regulations, as well as to create an environment conducive to continuous improvement in all aspects of the company.
“To provide the medical profession with quality products that meet applicable regulatory requirements. We will achieve this by creating an atmosphere of continuous improvement in our operation and maintaining an effective quality management system".
