Home > Capabilities > Quality


Quality you can trust.

Around the world, the word "quality" and "B. Braun" are synonymous. That holds true at B. Braun OEM where we have established stringent processes and monitoring practices for consistent quality. To meet international standards B. Braun has ISO 13485 certified facilities and systems. In addition, each location adheres to country-specific regulatory and licensing mandates.

B. Braun's US manufacturing facilities are FDA-registered, complying with quality system regulations (QSR) and have implemented statistical process control (SPC programs). The Quality Assurance Program is supported by a high-end laboratory located on the premises.  

In addition, our pharma site is in compliance with Good Manufacturing Practices (cGMP).  

Additional United States requirements include: 21 Code of Federal Regulations (CFR) 820 for Medical devices and 21 Code of Federal Regulations (CFR), Parts 210-211 for drugs.

Not all products are registered and approved for sale in all countries or regions. Please contact your country representative for product availability.