Medical Device Design and Development
Minnetronix has significant experience with the design and development of Class II and Class III electronics-based medical devices, combined with a solid track record of leading successful commercialization efforts from requirements through regulatory approval and production release.
Design Control is a key element of our quality system. You benefit from a structured development process that has been specifically developed to comply with the FDA's Quality System Regulation (QSR) and ISO 9001/ISO 13485 design control requirements. The design documentation that we deliver to you is ready to be packaged into your regulatory submission.
Capabilities and Expertise
The core of Minnetronix' design capabilities is embedded software and electronics systems, with a singular focus on medical product applications. Our software, electronics, and quality assurance engineers have extensive backgrounds in medical device development, and are continually involved in development projects, utilizing and developing state-of-the-art technology and products.
Our capabilities include:
- Safety-critical design methodology
- Broad system architecture experience
- Experienced project management
- User-centered design
- Design for manufacturability
- Design for regulatory compliance
- Design for Electromagnetic Compatibility (EMC)
Technical Experience
Along with embedded microprocessor technology, we also have specific expertise in the following areas:
- Motors and motion control
- Fluid pumping and control
- Graphical user interface design and development
- Sensors and signal processing
- Optical system integration
- Power systems and batteries
- Embedded network technology
Read the case studies describing some of the projects we've completed.
Learn More
To learn more about medical device design & development at Minnetronix, contact us at:
info@minnetronix.com or (651) 917-4060.
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