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Manufacturing

Minnetronix specializes in turnkey contract manufacturing of finished electronics-based medical devices, with a focus on high-complexity, low-to-medium volume devices. We are an FDA registered medical device manufacturer, and are ISO 9001 and 13485:2003 certified.

Expertise
At Minnetronix, our manufacturing teams have significant expertise in rapid scale-up and product turnaround, and deliver thoroughly tested, high-quality devices. In addition, you benefit from:

• Integrated technical support
  Our experienced manufacturing and design engineers team together to provide technical support for your product throughout the design and manufacturing processes. Each device undergoes rigorous testing by our engineers and technicians to ensure that all performance requirements are met.
• Cost-effective and efficient design transfer
  Minnetronix will smoothly transfer your product design into production, either from our own development team, or from an external source.
• Flexibility
  Minnetronix offers you a wide degree of flexibility in device volumes, size, schedule, and delivery options.

Process and Capabilities
The Minnetronix manufacturing process is customer-focused. Our manufacturing floor is organized into a cell-based structure. As your device transitions into production, we create a dedicated manufacturing cell for it where all production work is completed. This enhances the efficiency of our manufacturing and test processes, and gives your device a place to call "home."

Our manufacturing capabilities include:

• Complete delivery of fully functional medical devices
• Electromechanical, cable and printed circuit board assembly
• Complete production electrical safety testing per IEC 601, and FUS inspection
• Functional test, calibration, troubleshooting, and repair
• Depot repair, including updates and product enhancement installation
• Use of appropriate Lean, TQM, JIT, and other manufacturing practices

Read the case studies describing some of the projects we've completed.

Case Study:
AngioJet® Ultra Thrombectomy System

Case Study:
Cyberkinetics™ Andara Oscillating Field Stimulator

Case Study:
cPAX™ Aneurysm Treatment System