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Fort Myers, FL – March, 2025 — Poly X MedTech, LLC is proud to share that we’ve once again passed our ISO 13485:2016 certification audit. For us, this isn’t just another box checked—it’s a sign that our team keeps showing up, raising the bar, and doing things the right way for our customers and partners. ISO 13485:2016 is the international benchmark for quality management in the medical device world. Meeting this standard means our systems, processes, and people consistently deliver safe, reliable solutions. But more than that, it reflects how we work: focused, detail-oriented, and always looking for ways to improve. Our Team Makes the Difference Everyone here at Poly X MedTech has a part in this achievement. It’s about more than procedures and paperwork—it’s about pride in our craft and a drive to do right by those who count on us. As Joseph Smith, our Engineering Manager, put it:“Passing this audit, year after year, is the result of hard work at every level. It’s a culture thing. Everyone here owns quality—no exceptions.” We’re not standing still. The work continues, with fresh investments in technology, smarter processes, and ongoing training for our people. Our focus is simple: make life easier for our customers, keep improving what we deliver, and help shape a future where quality in healthcare keeps moving forward. Who We Are Based in Fort Myers, Florida, Poly X MedTech builds, assembles, and packages precision medical devices for innovators across the industry. We value straight talk, high standards, and real partnership—because we know that’s