Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, ISO 9001, FDA Registered
Markets Supplied: North America
Injection Molding and Full Service Contract Manufacturing
Flambeau Medical Markets Groups is a diverse manufacturing company providing a complete product fulfillment service for the medical device industry. We are an ISO 13485:2008 (CFR21 820 Compliant) certified contract manufacturing company with capabilities to support the manufacturing of FDA Class I, II, and III Devices.
We offer product development services, rapid prototyping, testing, molding, tool making, assembly, class seven clean room manufacturing, and manage sterile packaging. Our highly experienced medical device team is prepared to bring your components or complete medical devices to market. Bringing your product ideas to Flambeau ensures you will receive outstanding support, quality, and best cost solutions to better enable you to compete in the rapidly evolving world of medical device manufacturing.
Corporate wide, we have more than 50 blow molding machines ranging in shot capacity from 1 – 50 lbs. We operate both continuous extrusion and intermittent extrusion equipment. For medical applications, we have draped presses and portable clean rooms to provide a clean molding environment for part production. We are experienced a wide range of blow molding materials including HDPE, PP, ABS, PVC, PPO, Polyester, TPE and Nylon.
Flambeau Medical Markets Group provides complete commercialization services utilizing leading industry experts to ensure that all user inputs, human factors, validation requirements, processing, and final packaging requirement are scalable to production. Our core competencies in injection molding, blow molding, product development, quality systems, and packaging mean we can provide a complete portfolio of services and incorporate custom and proprietary solutions.
Medical applications include:
- Cardiovascular Devices
- Orthopedic Devices
- Wound Closure
- Respiratory Care
- Fluid Management – Connectors and Fluid Containers
- Packaging – Sterile and Non¬Sterile including re¬usable for sustainability purposes
- Injection and Blow Molding
- Product development (inputs to design control, writing protocols, PFMEA/DFMEA Analysis)
- Verification testing including destructive and functional
- Validation testing (IQ/OQ/PQ/PPQ)
- Prototyping (FDM, SLA, Machining, Aluminum Tooling, Inserted MUD Bases, or P-20 self-contained tools)
- Production Tooling (In house tool shop providing up to SPI Class 101 multi¬cavity molds for high volume production)
- Clean Room Molding and Assembly
- Epoxy/UV Curing/Chemical Bonding, Pouching, Mechanical Assembly
- Heat Staking and Ultra Sonic Welding
- Part Decoration
- Insert and Over Molding
- Quality Management Services
- Document Control (LHR, DHR, DMR)
Medical Component Manufacturing
Flambeau Medical is your outsourcing solution for components, sub-assemblies and complete products for the healthcare industry. Our ISO Class 7 Clean Room in Phoenix is capable of providing the highest level of performance on the manufacture and assembly of your products. With over six decades of polymer science and manufacturing expertise, we deliver excellence at every step of your product development timeline. Our independent, global organization with core competencies in injection molding, blow molding and contract manufacturing processes provide the edge to ensure your success. We also offer a full range of disposable and sustainable...