Product to Market Capabilities
Managing your project from brainstorm through delivery
When you need to accelerate the product development process and speed time to market – without jeopardizing quality or marketability – you can count on our project management capabilities. You have access to B. Braun's OEM Division representatives from various disciplines who will share their expertise in the areas related to your project, including:
- Quality Assurance
- Regulatory Affairs
- Product and Process Validation
Your project includes a dedicated team – an account manager, product engineer, quality engineer, regulatory analyst, customer service representative and sales coordinator – who helps meet your design, quality and regulatory requirements - and keeps your project on-time and within budget.
From initial development to successful product launch, the B. Braun's OEM Division is as committed to project management as they are about your project’s success.
Design & Prototyping
Where quality products begin
B. Braun's OEM Division has engineering centers worldwide to help design medical components, devices and kits. Our staff of knowledgeable design and manufacturing engineers and technicians works together closely to design a product that meets your requirements and keeps manufacturability in mind.
We offer full drafting capabilities using advanced CAD systems and conduct full mechanical and materials testing in-house. Our prototyping service allows you to evaluate critical characteristics such as material, size, function, ease of manufacturing and packaging early in development to help ensure market satisfaction.
Whether you are creating a new product or modifying an existing one, our design and protoyping capabilities will add value to your device or kit.
Support for compliance and registration
B. Braun has a complete in-house regulatory staff for both devices and drugs. Our analysts will review all labeling to ensure compliance with FDA and global regulations. We offer support in filing drug applications, 510(k)s, PMAs and CE markings and assist in the regulatory assessment of product changes. B. Braun can also provide NAFTA certificates and country-of-origin letters.
Supply Chain Management
Strengthening the supply chain
B. Braun helps eliminate supply chain inefficiencies. Using our extensive base of approved suppliers, we can generate purchasing efficiencies. B. Braun can save your company time and resources through collaborative inventory management for pull-based minimum/maximum and kanban management.
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 U.S. 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 pharmaceutical manufacturing site is in compliance with Good Manufacturing Practices (cGMP).
Additional U.S. requirements include: 21 Code of Federal Regulations (CFR) 820 for Medical devices and 21 Code of Federal Regulations (CFR), Parts 210-211 for drugs.