ABOUT US

Specialists in Ultra-Clean Silicone Molding

FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.

Since 1989, we have been supplying micro-precision molded components to leading medical device manufacturers and helping them expand their global market reach. We understand the intricacies of FDA requirements and global manufacturing standards and we aim to exceed them with our ultra-clean silicone molding facilities.

Our Chicago area headquarters and offshore manufacturing facility in Suzhou, China are both ISO 13485-certified with Class 5, 6 and 7 clean rooms.

We work with our clients to speed products to market through our rapid development program, while maintaining the highest quality and competitive pricing.

FMI Medical is a privately held company, owned by Flexan Corporation, founded in 1946, with more than 500 employees worldwide. ISO_13485_Medical_Devices_MONO_NO_SAI

FMI Capabilities

  • Molding
    • Liquid Injection Molding (LSR)
    • Injection Transfer Molding(HCR)
    • Compression Molding (HCR and LSR)
    • Desiccant/Silicone Rubber
  • Over-molding
    • Stainless Steels
    • Delrin
    • Titanium
    • PEEK
    • Nylon
    • 430FR
    • Brass
    • Aluminum
  • Custom Automation Solutions
    • Molding
    • Assembly
    • Inspection
    • More than 200 silicone components of FDA certified medical devices; >2M parts per year
  • Engineering
    • Sustainable engineering
    • Rapid prototyping support
    • Tool preservation
  • Secondary Operations
    • Cryogenic deflashing
    • specialty packaging
    • Assembly
    • Lapping
    • Grinding
    • Inspection
  • Supply Chain Management
    • Best cost country manufacturing
    • Sourcing
    • inventory management

MARKETS

  • Cardiac Rhythm Management
  • Neuro-stimulation/Neuro-Modulation
  • Urological
  • Ophthalmic
  • Orthopedic
  • Reconstructive Surgery
  • Surgical Devices
  • Miniature pneumatic components
  • Micro-precision components
  • Hearing aid components
  • Medical and diagnostic components
  • Hydraulic & pneumatic components
  • Industrial controls
  • Food and water handling products
  • Military and aerospace
  • Commercial electronics
  • Automotive and heavy truck components
  • CNG/LNG

Delivering Consistent Quality Assurance

  • Paperless traceability from person to press to part
  • Dock to stock capabilities minimizing incoming QC
  • Individual training and compliance monitoring
  • Tracks productivity output and efficiency
  • Tool maintenance and reporting capabilities
  • Provides real-time defect and root cause pareto analysis

CONTACT INFORMATION

FMI, Inc.

2382 United Lane

Elk Grove Village, IL 60007

UNITED STATES

Phone: 847-350-1535

Contact: Mike Hurias