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ISO 13485–Certified Contract Manufacturing
Poly X MedTech provides ISO 13485–certified cleanroom assembly and packaging services for medical device companies. We support controlled manufacturing steps where cleanliness, documentation, and repeatability are critical to device quality and regulatory compliance.
Medical devices demand strict contamination control. Uncontrolled environments increase risk, rework, and regulatory exposure. Our cleanroom operations help customers:
Protect device integrity
Meet ISO 13485 and FDA quality expectations
Reduce internal manufacturing complexity
Scale without investing in in-house cleanroom infrastructure
We operate under a disciplined quality system with defined processes, trained personnel, and documented controls.
Our services include:
Cleanroom component and device assembly
Cleanroom packaging and labeling support
ISO 13485–aligned process documentation and controls
Engagement starts with a short scope review to align requirements, volumes, and timelines—then moves quickly into execution.
Work with us when you need:
Cleanroom assembly or packaging support
An ISO 13485–certified manufacturing partner
Pilot builds or scalable production support
A compliant alternative to building internal cleanroom capacity
If your program requires cleanroom manufacturing done right, we’re ready to support it.
Contact: David Masingill, Business Development Manager
Email: dmasingill@polyxmedtech.com
With a comprehensive suite of services covering the entire product lifecycle, including assembly, and Non-Sterile or Sterile packaging in a Class 10,000/ISO 7 Certified Cleanroom space, Poly X MedTech streamlines production. Our diverse manufacturing capabilities and expert team enable efficient processes, ensuring timely delivery and meeting the demands of the dynamic medical device industry.
Poly X MedTech places paramount importance on quality assurance. Devoted to upholding the highest standards, we adhere to ISO-13485 and other relevant quality management systems. This commitment guarantees that every product we manufacture maintains consistent quality, complying with stringent industry regulations and exceeding customer expectations.
Recognizing the challenges in the medical device industry, Poly X MedTech is committed to being a reliable and adaptive partner. Our collaborative approach involves making realistic promises, understanding customer needs, and delivering on time. We manage our growth deliberately, staying agile and responsive to market demands, ensuring adaptability to evolving client requirements.
Cost transparency is a core principle at Poly X MedTech. Our clients benefit from clear and comprehensive cost structures based on generally accepted manufacturing accounting principles. This transparency fosters trust and collaboration, empowering our clients to make well-informed decisions and ensuring that they receive exceptional value for their investment.
Poly X MedTech is deeply committed to integrating sustainable environmental guidelines into our corporate DNA. This commitment is exemplified by our practices such as the utilization of eco-friendly materials in our manufacturing processes, reducing waste through efficient recycling programs, and implementing energy-efficient technologies. We prioritize suppliers with strong environmental practices, ensuring a sustainable supply chain. Our dedication to sustainability extends beyond compliance, and we actively seek innovative solutions to minimize our ecological footprint. By embedding environmental responsibility in our core values, Poly X MedTech strives to contribute positively to both the medical industry and the planet.
Let us show you the Poly X Medtech difference.
Becoming a client of Poly X MedTech brings a manifold of benefits. Our expertise in FDA-regulated manufacturing ensures the production of precise Class I-III medical devices, translating ideas into high-quality products.
(239) 329-0007