Medical Markets Group

Flambeau Medical Markets Group a division of Flambeau, Inc., is a full-service medical contract manufacturing company. We provide a full range of development and manufacturing services, including product design assistance and development, engineering, prototyping, and mold design and manufacturing. We have conventional and clean room molding capabilities, as well as secondary operations and assembly.

Our dedication to delivering quality product makes Flambeau Medical Markets Group a leading supplier to the medical marketplace. Through efficient and transparent communication with our customers, Flambeau meets the medical industry’s most stringent requirements. We serve Fortune 500 companies in cardiovascular and orthopedic device, women’s health, aesthetics, wound closure, infusion care, respiratory care, fluid management, and packaging market segments.

Quality

Flambeau Medical’s quality management system (QMS) is FDA compliant and certified to ISO9001:2015, ISO13485:2016 and CFR21 820 standards. At the heart of this system is our goal to fully satisfy each customer’s expectations through a committed team effort. Compliance with Flambeau’s QMS results in continuous improvement in every part of our business is fully integrated with our manufacturing operations and provides training for certified line leads and operators.

In addition to standard maintenance of Device Master Records, Device History Records, and material lot controls, Flambeau’s specific functions and services include:

• APQP Development
• Programmable Vision Systems
• CMM
• Window Studies
• Gage R&R
• Bioburden Testing
• Dose Mapping
• CPK Studies
• Destructive testing
• Bench testing
• IQ/OQ/PQ

Certifications