Fort Myers, FL – March 2025 — Poly X MedTech, LLC is pleased to announce the successful completion of its ISO 13485:2016 recertification audit, reaffirming the company’s commitment to quality, compliance, and disciplined execution in medical device manufacturing.
ISO 13485:2016 is the internationally recognized standard for quality management systems in the medical device industry. Recertification confirms that Poly X MedTech’s systems, processes, and controls continue to meet rigorous regulatory and customer requirements while supporting consistent, reliable outcomes.
A Team-Driven Commitment to Quality
This achievement reflects the collective effort of the Poly X MedTech team and a shared responsibility for quality across the organization. As Joseph Smith, Engineering Manager, noted:
“Successfully completing this audit year after year reflects the consistency of our processes and the accountability our team brings to quality at every level.”
Looking Ahead
Poly X MedTech remains focused on continuous improvement, with ongoing investments in technology, process optimization, and employee training. The company’s priority remains clear: deliver dependable solutions, strengthen customer partnerships, and support innovation in healthcare manufacturing.
From Business Development
David Masingill, Business Development Manager, added:
“ISO 13485 certification gives our customers confidence that quality is built into everything we do. It’s not just a requirement—it’s how we operate.”
About Poly X MedTech
Based in Fort Myers, Florida, Poly X MedTech provides medical device manufacturing, assembly, and packaging services to innovators across the industry. The company is committed to high standards, transparency, and long-term partnership.
For more information, visit PolyXMedtech.com or contact David Masingill at dmasingill@polyxmedtech.com.
Subscribe to our Newsletter & Event right now to be updated.