Medical Manufacturing Solutions
Flambeau Medical is a full-service, contract manufacturing organization serving the medical device and life Sciences industries. Each member of our executive leadership team comes with a minimum of 20 years serving in the industry. We provide a full suite of development and manufacturing capabilities in our FDA registered and ISO-13485:2016 certified manufacturing operations located in Phoenix, Arizona. Flambeau Medical produces medium-to-high volume molded components, secondary operations, fully automated assemblies, Class II finished device manufacturing, and sterile barrier packaging in our Class 7 & Class 8 clean rooms. We proudly serve many of the world’s leading medical device manufacturing companies.
Flambeau Medical’s quality management system (QMS) is FDA registered 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 Medical’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 Manufacturing Solutions 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 Medical’s specific functions and services include:
• Programmable Vision Systems
• Window Studies
• Gage R&R
• Dose Mapping
• CPK Studies
• Destructive testing
• Bench testing