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 packaging solutions including stock cases for Cardio, Orthopedic, Spinal, In Vivo and Surgical devices. Whatever your needs, we stand ready to assist and deliver quality performance and competitive prices.
Molds, Tooling & Automation
Flambeau has two tool rooms (Wisconsin and Arizona) that build both injection molds and blow molds. Our shops have more than 40 year experience in building all types of tooling from quick aluminum prototype and pilot production molds to Class 101 tools for high volume precision injection and blow molding. Close tolerance tooling and fixtures for molded medical components are produced using state of the art CNC Machining, Wire EDM and Sinker EDM equipment. We also have partners in Asia and Europe that can support low cost tooling options when time is not a factor.
Our automation department has a full range of capabilities from simple fixtures to complex work centers that can drill, tap, cut, weld, assemble and test components and products. Barcoding can be integrated into the work center or as a stand-alone system in compliance with APQP and manufacturing process instructions. Flambeau Technologies Tool Group will design and build discrete equipment for product validation, functional testing and destructive testing.
Corporate wide, we have more than 175 injection molding machines ranging in clamping force from 30 – 1,775 Tons. We operate both hydraulic and electric presses with robotic systems for part removal, trimming and assembly. Our Class 8 molding environment used state of the art electric presses that are less than five years old. We are experienced in the full spectrum of molding materials including PEEK, PVC, Ultem, Polyesters, POM, PPS, PPO, PES, PAS, PC, Nylon, TPE, Olefins and other commodity resins.
Medical Device Assembly
Ensuring compliance via fully qualified processes as soon as proof-of-concept prototypes are complete, our creative approach to assembly and automation results not only in higher levels of statistical quality, but smaller batches and lower costs. We develop systems that are scalable and flexible enough to work with rapidly changing demands. Our modular approach to automation and our in-house design and development teams understand the rigorous demands and functional requirements for high volume/high speed assembly.
Packaging has been a core competency of Flambeau for decades. We offer a complete line of stock cases, totes and trays for components, instruments and complete products. Our custom packaging solutions can be configured for your specific application.
Flambeau offers a variety of decorating options for your molded components or finished product:
- Pad printing
- Hot stamping
- Custom painting
- IMD In-Mold-Decorating for injection molding
- IML In-Mold-Labeling for blow molding
- Silk screening
New Product Development
We can assist with developing concepts/ideas into products using our support teams that have expertise in Industrial Design, Part Design, Design for Manufacture as it relates to repeatable processing in a variety of manufacturing methods; strong knowledge of predicate devices in the industry, best-in-class methods of manufacturing; and designing to protect or strengthen IP.
For more information contact Flambeau Medical Group