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 cleanroom 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 devices, women’s health, optical equipment, 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, ISO13485 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. If you are in need of one of our quality certificates, please contact your Flambeau Medical Markets Group representative or by visiting our contact us page.
In addition to standard maintenance of Device Master Records, Device History Records, and material lot controls, Flambeau’s specific functions and services include:
• Programmable Vision Systems
• CMM
• Window Studies
• Gage R&R
• Dose Mapping
• CPK Studies
• Destructive testing
• Bench testing
• IQ/OQ/PQ