Minnetronix - Medical Device Design & Manufacturing

To us, quality is never letting the customer, clinician or patient down.

We’ve created a sophisticated, proprietary electronic data management system to automate and document the design and manufacturing processes. Auditors have called our system “a benchmark in electronic record keeping.”

Continuous improvement 
We’re dedicated to ensuring that our quality systems maintain compliance in an evolving regulatory environment. Our expertise in regulatory affairs ensures your device measures up to the most current, rigorous quality standards of the device industry.

FDA registered (#2133810), ISO 9001
and ISO 13485 certified

Our quality system encompasses design, development, manufacturing, commercialization and repair of medical electronic products. We have undergone four successful FDA QSIT inspections with no action indicated (2010, 2008, 2004 and 2001)... more

  1. Case Study /  PlaCor | Platelet Reactivity Technology

    Where did PlaCor find the quality systems to support effective development of their complex technology?

    Physicians are aware that up to 50% of patients who are prescribed aspirin, Plavix® or other anti-platelet medications have little or no response to the therapy. This leaves patients at risk for an adverse cardiac event. To help physicians determine therapy efficacy, PlaCor developed a technology to measure the effectiveness of anti-platelet drugs to inhibit the clot formation that can result in heart attack or stroke.

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    PlaCor | Platelet Reactivity Technology
  2. Case Study /  PlaCor | Platelet Reactivity Technology

    Platelet Reactivity Test Providing quality and document control systems throughout development

    PlaCor partnered with Minnetronix for product design, verification and scale-up to manufacturing. Minnetronix engineers worked on the sensing system, optical design, software, hardware and electronics design. Minnetronix also took on the mechanical design, and developed the feasibility prototype as well as the production-ready console. Throughout the development process, PlaCor relied upon the established Minnetronix quality system to ensure quality and documentation requirements were met. This allowed PlaCor to focus on broader business and product development opportunities, without having to implement new processes and systems.

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    PlaCor | Platelet Reactivity Technology

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