We are experts in designing electronic and electromechanical systems for performance, reliability, and regulatory compliance.
With a singular focus on medical applications, our software, mechanical and electrical engineers develop state-of-the-art technology and products. Our long history in electromechanical medical devices has given our teams specialized skills and abilities that we apply to each project from small implantable devices to large-scale integrated instruments and systems.
Minnetronix uses a systems approach to the analysis and design of medical technologies that demonstrates both control and agility. Our unique systems-based process and effective program management allow us to tackle and resolve particularly complex systems challenges. We deliver intelligent, practical solutions from design through build, while appropriately balancing cost and complexity. The Minnetronix development process assures that the needs for performance, speed-to-market, and cost-effectiveness are met.
Expert-Level Compliance with Medical Device Requirements
Minnetronix’ engineers are focused on the commercialization of software, mechanical and electronics-based medical devices, primarily Class II and Class III products. Our processes are specifically designed to meet FDA and ISO requirements for design and production controls. Minnetronix is FDA-registered with a full quality management system in place and a track record of five consecutive FDA inspections resulting in No Action Indicated, the most favorable possible outcome.
All of the products we design and build are subject to international product safety requirements for medical devices. Our engineering team has expertise in EN 60601-1 as well as the associated collateral and particular standards. We have successfully guided dozens of products through compliance testing and registration with safety agencies including UL, TUV, Intertek, CSA and others.