About Us
Typhon Catheter LLC
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At Typhon Catheter LLC, our team comes together every day in a 2,160 sq. ft., Class-8 cleanroom with a shared purpose: to design and manufacture world-class medical devices and components that meet and exceed the highest regulatory standards.
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We utilize advanced processes, precision plastic processing, and quality-driven practices to ensure excellence in every product we deliver. In healthcare, every detail matters—our work reflects that responsibility.
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​Our Mission
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Our mission is to be industry leaders in plastic processing for medical devices, while fostering a friendly, family-oriented culture. We are passionate about supporting:
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Healthcare professionals striving for better patient outcomes
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Startups bringing new ideas to market
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Established companies seeking reliable, high-quality manufacturing partners
From concept to commercialization, we partner with you every step of the way to bring innovative medical solutions to life.
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​​Why Choose Us?
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With over 15 years of experience in contract medical device manufacturing, our skilled and passionate team is uniquely equipped to:
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Deliver customized medical components and assemblies
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Ensure compliance with ISO 13485:2016 and FDA QSR (21 CFR Part 820)
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Exceed industry expectations for quality, traceability, and performance
We don’t just make parts—we create solutions that empower the future of healthcare.
📞 Call us today at 651-428-6207 to discuss your specialized manufacturing needs.
Leadership Commitment
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Our CEO and executive team set the tone for our entire organization by making quality and compliance our highest priorities. Every decision we make—from process design to product delivery—is guided by our commitment to meeting ISO 13485:2016, FDA QSR (21 CFR Part 820), and international regulatory standards.
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Even our CEO is ISO 13485:2016 Lead Auditor Certified and a Certified Quality Manager – Medical Devices, demonstrating that leadership itself is deeply engaged in the standards, regulations, and best practices that govern our industry.
This leadership-driven focus ensures that:
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Quality is built into every step of our operations.
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Compliance is never compromised, regardless of cost or timeline.
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Our team is empowered to uphold a culture of accountability, transparency, and continuous improvement.
At Typhon Catheter, quality and compliance are not just standards to meet—they are the foundation of everything we do.​
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