Medical Device Qualified Supplier Directory
Minnetronix Inc. Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe
For over 15 years, Minnetronix has combined design and manufacturing, and our own innovative IP solutions, to help customers transform ideas into commercial success. Our teams expand the boundaries of device performance to create sophisticated medical devices that reliably meet regulatory and market needs, and help achieve customers’ goals for market introduction, product performance and business success.
Minnetronix designs and manufactures a wide variety of Class II and Class III medical products including therapeutic devices, diagnostic instruments, cardiovascular devices, monitoring equipment, and implantable devices. Our development team has significant technical expertise with the design of software and electronics-based products, combined with a solid track record of leading successful commercialization efforts from requirements through regulatory approval and production release.
Minnetronix focuses 100 percent on the medical industry, and has led over 200 design and manufacturing projects for 125 different medical device and life science firms, ranging in size from small start-ups to Fortune 50 companies.
Cornerstone to Minnetronix is a knowledgeable and experienced technical team that is continuously immersed in complex medical technology programs. With consistently high employee retention, we offer sustained value by aligning our resources with customers’ program requirements such as:
- usability and interface design
- signal and image processing
- safety-critical software
- wireless device connectivity
- electromagnetic compatibility
- sophisticated control algorithms
Managing manufacturing through product validation and the early stages of market release requires expertise and flexibility. Our product manufacturing services are tailored to support customers through the complete product lifecycle, and include:
- highly-complex finished devices and systems
- design and manufacturability and testability
- comprehensive supply chain management
- custom functional test systems
- continuous lean initiatives
- flexible production volumes
Beyond manufacturing, Minnetronix’ commercialization services integrate product order fulfillment, sustaining and value engineering, obsolescence redesign and full depot repair.
With effective processes and a proprietary quality system that exceeds industry standards, Minnetronix assists customers in mitigating risk and complying with FDA and international regulations. Our structured, but agile quality system allows us to tailor our services to meet individual program needs and to achieve the best results.
Minnetronix is an FDA-registered Medical Device Manufacturer and is ISO 9001-certified.