Flexan is a global contract manufacturer and assembler, specializing in custom, high-precision Silicone, Rubber and Thermoplastic components and devices. We offer contract manufacturing services for a broad array of implantable/highly invasive medical devices, including catheter sets and components. Our manufacturing footprint consist of three locations in Lincolnshire, IL, Salt Lake City, UT and Suzhou China. We manufacture over 120M parts across 1,700 SKUs each year. We operate in certified and accredited cleanroom manufacturing facilities. Our competencies focus on the design, development and manufacturing of individual components or fully/sub-assembled devices in silicone or thermoplastic materials. We offer a wide-variety of molding and extrusion capabilities.

FLEXAN CAPABILITIES

• Molding
• Extrusion/Tubing
• Medical Device Assemblies
• Process Development
• DFM/Design Assistance
• Prototyping
• Automation

• Wound Care
• Oncology
• Vascular
• Diabetes
• Neurology
• Ophthalmology
• ENT
• Cardiology
• Orthopedic
• Respiratory
• Gastrointestinal
• Renal
• Urology
• Gynecology

MARKET SEGMENTS

• Imaging
• Monitoring
• Surgery
• Infusion
• Modulation
• Electrophysiology
• Access
• Interventional

QUALITY ASSURANCE

At Flexan, following ISO, FDA and other international quality standards and industry practices is only the start. We weave quality assurance into every step of the manufacturing process, from design, process development to final production. Flexan applies that knowledge of industry best practices in quality with all of our clients.

Our QMS spans the following activities:

• Pre-Production Quality Assurance (QA)
• Product Quality Control (QC)
• Regulatory Affairs & Compliance (RA)

Certificates:

• Flexan Lincolnshire
  • ISO 13485:2016
  • FDA Registered
• Flexan Salt Lake City
  • ISO 13485:2016
  • FDA Registered
• Flexan Suzhou
  • ISO 13485:2016
  • ISO 9001:2015