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GMP Compliance

Providing quality products and services for over 45 years

B. Braun acknowledges that to be truly competitive in today’s market, we must have a quality system that governs all phases of business operations to guarantee our customers will consistently receive the quality products and service 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 4, 820, 210, 211; Medical Devices Regulations (EU) 2017/745; MHLW/PMDA the Canadian Medical Device Regulations, Canadian Food and Drug Regulations (C.R.C., c. 870), Part C, Division 2, Korean GMP for Medical Devices, Swiss Medical Devices Ordinance (MedDO) SR 812.213, United Kingdom (UK) Medical Devices Regulations (MDR) 2002 (SI 2002 No. 618) and is conducive to continuous improvement in all aspects of the company. 

Related Documents

  • PA EN ISO 13485:2016, Certificate No Q5 044904 0046, Rev 03, Exp 2027-09-04

    pdf, 341.5 KB

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  • PA MDSAP ISO 13485:2016, Certificate No. QS6 044904 0053, Rev 04, Exp 2027-09-17

    pdf, 421.7 KB

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  • B. Braun MDR Class I sterile – G11 044904 0056, Rev 00, Exp 2027-09-22

    pdf, 273.9 KB

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  • B. Braun MDR Class II – G10 044904 0057, Rev. 00, Exp 2027-09-22

    pdf, 274.2 KB

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  • DR EN ISO 13485:2016 Certificate No. Q8 040410 0008 Rev 00, Exp. 2027-04-21

    pdf, 415.4 KB

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  • TX MDSAP ISO 13485:2016, Certificate No. QS6 045700 0005, Rev 05, Exp 2026-11-16

    pdf, 417.4 KB

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  • PA EN ISO 11135:2014+A1:2019 Supplement Certificate No 44904 0055, Rev 02

    pdf, 226.8 KB

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  • Korean KCL-BBAA-16415: B. Braun Dominican Republic, Exp 2026-02-01

    pdf, 390.5 KB

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  • Korean Certificate: KCL-BBAA-20543, B. Braun US Device Manufacturing LLC, PA – Exp. 2027-05-06

    pdf, 93.9 KB

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  • B. Braun Medical Inc., Dominican Republic - Japan FMA Certificate, No. BG32300005, Exp 25-09-2027

    pdf, 265.9 KB

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  • B. Braun Medical Inc. and B. Braun US Device Manufacturing LLC – Japan FMA Certificate, No. BG30403747, Exp 12-10-2028

    pdf, 253.1 KB

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  • Korean Certificate: KCL-BBAA-19384, B. Braun – 12th Ave, PA-Exp. 2027-01-01

    pdf, 255.9 KB

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  • Taiwan Certificate: QSD1597, B. Braun US Device Manufacturing LLC – 901 Marcon, PA – Exp 2027-10-28

    pdf, 143.7 KB

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  • B Braun Medical Inc. – EU MDR 2023-607 Confirmation Letter 044904 0058 Rev 03

    pdf, 456.5 KB

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