Medical Device Qualified Supplier Directory
Flexan LLC Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, Supplier to Medical Manufacturers
Markets Supplied: Worldwide
Flexan is a global manufacturer that delivers cleanroom manufactured, assembled and packaged molded components (silicone and thermoplastic) for use in implantable Class III devices and disposable Class II and Class I medical devices.
Flexan provides highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability. Flexan specializes in ultra-clean silicone molding components for Class II and Class III medical devices, such as implantable cardiac rhythm devices, implantable neurostimulation devices, orthopedic implants, breast implants, dental implants and intraocular lens.
· ISO 9001-2008 & 13485 and FDA Registered
· Speed to market via rapid development program and design assistance
· Expertise in customer/ FDA requirements and global manufacturing standards
Flexan specializes in custom molding of thermoplastic components for Class II and Class III medical devices.
ISO 13485:2003 & 14644 and FDA Registered
Clean room manufacturing for ISO Class 8, (100,000) Expanded capabilities include thermoplastic insert and injection molding, extrusion, tip forming, hole drilling, printing, laser marking, finished device assembly along with sub-assembly, packaging and sterilization.
of custom, high-precision silicone and thermoplastic components primarily used in medical devices, as well as hearing technologies, industrial controls, aerospace and defense, and miniature pneumatics.
Our our end-to-end capabilities include:
- Design for manufacturability
- Rapid prototyping P
- Process validation (IQ, OQ, PQ)
- Extrusion/Tubing (Thermoplastic and Silicone)
- Secondary operations, including hole drilling
- Logistics and distribution
- Manufacturing management and sustainability
- Lean Six Sigma methodologies
Flexan produces 140 million parts with a quality measure of 99.9%. In fact, 80 percent of our business is delivering products for top Class III medical device companies. We have been serving our global customer base for over 70 years. To learn more, contact us at: [email protected]
Our engineers work with each client to determine the best molding process, tool design, and manufacturing controls for the application, in keeping with the client’s material preferences and plans for manufacturing (DFM) and assembly.
CUSTOM SILICONE MOLDINGS REQUIRE DIFFERENT SILICONE MOLDING PROCESSES Our engineers recommend the optimal molding process for each application, based on the silicone material specified by the manufacturer and the expected production volume.
Our processes include:
- Silicone Extrusion/Tubing
- Liquid Injection Molding
- Transfer Molding
- Compression Molding
- Silicone to Metal Bonding / Insert Molding
Medical grade silicone is the material of choice for medical device components that require high performance and safety when in short or long term contact with the human body.
OUR COMPONENTS ARE PRODUCED IN AN “ULTRA-CLEAN” FACILITY Nearly 75 percent of the silicone components we produce are Class III implant-grade components. Our custom silicone components are produced in our advanced ultra-clean Class 5 clean room facilities, going beyond the basic requirement of Class 7 clean rooms for medical device component manufacturing.
- Long-Term Implantable Silicone Components for Class III Medical Devices
- Short-Term Implantable Silicone Components for Class II Medical Devices
- Disposable Silicone Components for Class II Medical Devices
We incorporate best practices, a defined process, and continuous improvement to deliver zero defects and reliability with on-time delivery and global distribution.
- Design & Engineering
- Rapid Development Program
- Process Validation
- Assembly & Secondary Operations
- Logistics / Distribution
- Manufacturing Management / Sustainability
Whether a U.S.-based client chooses to manufacture in China, the U.S. or both facilities, our U.S. staff members oversee each project, serving as liaison to our managers in China as required. All projects, whether manufactured in the U.S. or China, are quoted in U.S. dollars to avoid currency exchange issues.
- Dual Capabilities - Flexan maintains dual tooling and molds and advanced manufacturing systems in both facilities to ensure quality and availability.
- Security - We safeguard our clients' proprietary data and intellectual property on a secured hard drive, with limited, authorized access.
- Competitive Costs - Our China operation combines lower-cost, highly skilled labor with the same advanced molding practices as the U.S., providing an attractive offshore option, particularly for companies that ship to Asia and the Pacific.
- Wholly Foreign Owned Enterprise (WFOE) in China - Flexan does business in China as a WFOE, which offers such advantages as the ability to operate without a Chinese partner, protection of technology and intellectual property, and no special requirements for import/export licensing.
- Clean room manufacturing for ISO Classes 5, 6 and 7 (100, 1000, and 10,000)
- 20,000 square-foot manufacturing, warehouse and distribution facility
- Special silicone/desiccant mixing and molding technology, automated assembly, automated measurement system
Flexan Suzhou Certifications: ISO 9000: 2008; ISO 13485
- Clean room manufacturing for ISO Class 7 (10,000)
- 6,000 square-foot manufacturing, warehouse and distribution facility
- Automated measurement systems
- Secured information systems and paperless operations to protect intellectual property
- Skilled labor force with managers fluent in English
- Commitment to international safety standards
- Ability to import U.S. medical-grade silicone as needed
- Expertise in import/export requirements, inventory management, and logistics worldwide
For more information contact Flexan LLC
Block 67, Dongjing Workshop, No. 25 Dongfu Rd.
T +86 512 881 86565
F +86 512 881 6566