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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 13485:2016, 21 CFR Parts 820, 210, 211, the Medical Device Directives 93/42/EEC and 2007/47/EC (MDD), MHLW/PMDA 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 ISO 13485:2016 MDSAP Certificate No. QS6 044904 0053 Rev. 00
pdf (493.9 KB)
PA EN ISO 13485 2012 – AC 2012 Certificate No. Q1N 044904 0049 Rev.00
pdf (169.2 KB)
DR EN ISO 13485:2016 Certificate No. Q6 040410 0005 Rev. 00
pdf (120.7 KB)
TX ISO 13485:2016 MDSAP Certificate No. QS6 045700 0005 Rev. 00
pdf (263.7 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)
B. Braun Medical Inc. 93/42/EEC Certificate Extension Letter
pdf (71.1 KB)

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