Manufacturing Center

  • Minneapolis, Minnesota
  • 10,000 ft2 newly renovated facility with expansion rights
  • Engineering, development and manufacturing
  • Certified Class 10,000 Clean Room
  • Sterile Kitting and Packaging
  • Low and High Volume Manufacturing
  • Analytical Chemistry Lab and Chemical Manufacturing
  • 3D Rapid PrototypingFacilities

    Development and Manufacturing Center
    – Minneapolis, Minnesota
- 10,000 ft2 newly renovated facility with expansion rights
    – Engineering, development and manufacturing
- Certified Class 10,000 Clean Room

    Key Capabilities & Expertise
    – Assembly, Testing and  Packaging
    – Adhesive Bonding, Curing
, UV Curing Systems
    – Soldering, Laser and Resistance Welding
    – Thermoplastic Injection Molding
    – Pad Printing and Silicone Curing
    – Robotics and Automation
    – Equipment and Tool design and manufacturing
    – Lean Manufacturing and Six Sigma
    – Supply Chain Management
    – Catheter Design & Construction (Braiding / Coiling, Reflow, Tipping)

    Quality Management System
    Certifications
    ISO – 13485:2003 Certified
    ISO – 14644-1: Class 7/10,000
    Compliance
    FDA – 21 CFR Part 820
    CMDR – Canadian Medical Device Regulations
    MDD – Medical Device Directive 93/42/ECC