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Accreditations and Certificates


Providing quality products and service for over 40 years

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.

  • Accreditations

  • EN ISO 13485:2012 + AC:2012 Certificates for PA Facilities
  • ISO 13485:2003 CMDCAS Certificate for PA Facilities
  • ISO 13485:2003 MDSAP Certificate for Carrollton, TX Facility
  • EN ISO 13485:2012 + AC:2012 Certificate for Dominican Republic Facility
B. Braun Medical Inc. Quality Policy

Quality is our CORE:

  • Customer Focus/Patient First - We are committed to total customer satisfaction
  • Operational Excellence - We strive for zero defects through continuous improvement
  • Revenue Growth/Profit Growth - We understand that quality is essential to our business
  • Employee Commitment - We are engaged employees that uphold the highest standards of quality and compliance

We achieve this by complying with applicable regulatory requirements and maintaining an effective Quality Management System.