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GMP Compliance

Providing quality products and services for over 40 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 820, 210, 211; Medical Devices Regulations (EU) 2017/745; the Medical Device Directives 93/42/EEC and 2007/47/EC (MDD); MHLW/PMDA and the Canadian Medical Device Regulations and is conducive to continuous improvement in all aspects of the company. 

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