GMP Compliance

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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)
DR EN ISO 13485:2016 Certificate No. QS6 040410 0007 Rev. 00 Exp. 2024-04-22
pdf (337.2 KB)
TX ISO 13485:2016 MDSAP Certificate No. QS6 045700 0005 Rev. 01 Exp. 2022-02-09
pdf (457.5 KB)
B. Braun Medical Inc. 93/42/EEC Certificate Extension Letter
pdf (71.1 KB)
PA EN ISO 13485:2016 Certificate No Q5 044904 0046, Rev 00
pdf (162.4 KB)
PA EN ISO 11135:2014 Supplement Cert: 044904 0047, Rev 00
pdf (119.5 KB)
B. Braun Medical, Inc. - EC Cert: Class I sterile # G2S 044904 0051, Rev 00
pdf (224.6 KB)
Korea GMP: KCL-BBAA-7508 BRDR-BBMUS
pdf (511.2 KB)
B. Braun Medical, Inc. – EC Cert: Class IIa, IIb, III, # G1 044904 0052 Rev 00
pdf (125.1 KB)
B. Braun Medical, Inc., Dominican Republic - Japan FMA Certificate, No. BG32000005
pdf (255.2 KB)
B. Braun Medical, Inc., Allentown, PA - Japan FMA Certificate, No. BG30400385
pdf (250.7 KB)

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