Manufacturing Operations

Minnetronix offers medical device manufacturing services and experience tailored to support you anywhere in your product's lifecycle.

Extensive Experience Manufacturing Highly Complex Medical Devices

Since 1996, we have built products ranging from neuro-stimulation systems and RF devices to blood pump controllers and blood analyzers, surgical lasers and high energy ultrasound ablation systems. Our manufacturing assemblers and technicians are skilled and experienced in building high-complexity medical products. We have specific expertise in manufacturing devices with embedded, safety-critical medical software.

Integrated with product development, we offer complete turnkey manufacturing of finished instruments and sustaining engineering, ongoing production engineering support, and service. Our product manufacturing services are tailored to support you through the complete product lifecycle, and include:

  • Comprehensive supply chain management
  • Continuation engineering
  • Depot service
  • Flexible production volumes

Expert Level Compliance with Regulatory Standards

We excel at manufacturing to meet exacting FDA and ISO standards; we are FDA registered (#2133810) and ISO 13485 certified. We have undergone seven successful FDA Quality System Inspection Technique (QSIT) inspections with No Action Indicated (2017, 2016, 2015, 2010, 2008, 2004 and 2001).

Product Performance and Patient Experience

Minnetronix views the market through the lens of a medical device company. Our Product Performance Management (PPM) philosophy incorporates the total cost of ownership, including reliability and performance trends, life cycle analysis, field complaints, and end-user experience. We add value by monitoring the entire stream of data sources, identifying trends, and implementing corrective actions to improve quality and field performance. We understand the rigors and scrutiny you face in this industry, and we can help you succeed with processes for reporting requirements, regulatory surveillance, and due diligence investigations.

Quality through Our Lean Production Environment

Our precise Lean Six Sigma production environment ensures the highest level of quality at every touch point, from sourcing to testing to shipping. As a product line moves through development into full production, we use many Lean and Six Sigma tools, including Visual Factory Management, Lean Material Movement, DMAIC and a 5S program, to ensure that we meet your goals throughout our manufacturing process.

When a production cell is set up, concepts such as load leveling and part flow are taken into account. Kaizen methodology and Continuous Improvement Boards are used throughout production to improve outcomes. More than just implementing Lean Six Sigma tools and methodologies, Minnetronix is committed to a culture based on these concepts.