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Providing quality products and service for over 40 years

B. Braun Medical Inc. 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 ISO 13485:2016, EN ISO 13485:2012/AC:2012, 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.

Related Documents

Description Document Link
PA EN ISO 13485 2012 - AC 2012 Certificate No. Q1N 44904 0044
pdf (169.2 KB)
DR EN ISO 13485 2012 - AC 2012 Certificate No. Q2N 17 07 40410 004.pdf
pdf (650.0 KB)
TX ISO 13485:2016 MDSAP Certificate No. QS6 045700 0005 Rev. 00
pdf (263.7 KB)
PA ISO 13485 2003 CMDCAS Certificate
pdf (248.9 KB)
MDSAP Audit Performed Confirmation Letter
pdf (182.3 KB)
Letter for EN ISO 13485:2016 Certificate No. Q1N 044904 0049 Rev. 00 for B.Braun Medical Inc. PA
pdf (76.6 KB)
Letter for EN ISO 13485:2016 Certificate No. Q2N 17 07 40410 004 for B.Braun Medical Inc. DR.
pdf (58.4 KB)

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