Medical Device Manufacturers
Polyzen LLC
1041 Classic Rd, Apex, NC 27539, United States
- Founded 1991
- ISO 13485:2016, ISO 9001:2015
- Prototype to full-scale production
About Polyzen LLC
Polyzen LLC was founded in 1991 by polymer chemist Tilak M. Shah in Apex, North Carolina, to serve as a contract developer and supplier for medical device OEMs and start-ups. Now part of the Solesis family of companies—alongside Secant Group, SanaVita Medical, and Charter Medical—Polyzen operates a 75,000-square-foot facility near the Raleigh-Durham research corridor. The company develops and manufactures customized polymer-based materials, films, components, and finished assemblies for medical devices. Its processing capabilities span elastomer and silicone formulation, specialty film extrusion, barrier films and laminates, dip molding and coating, stent and wire coatings, low- and high-pressure balloon production, multi-layer balloons, catheter fabrication and assembly, lay-flat sheathes and tubing, thin-film welding, and thermoforming. Polyzen supports projects from prototype through full-scale production, offering validation, packaging, and sterilization management under one roof. Polyzen serves the medical device and life sciences sectors, working with entrepreneurial start-ups as well as major OEMs developing Class I, II, and III devices. Its quality system complies with FDA cGMP (21 CFR Part 820), ISO 13485:2016, ISO 9001:2015, and Japanese MHLW requirements, enabling global supply. The firm’s stated mission is to accelerate product realization by acting as an extension of customers’ engineering and manufacturing teams. Core principles emphasize urgency in turning ideas into solutions, attention to detail in quality and sustainability, and creating value for patients. Integrated R&D with sister companies further expands its material science and processing expertise.
Manufacturing capabilities
Core processes
Finishing & coating
Inspection & quality
Assembly & services
Industries served
- Medical Devices
- Life Sciences
Materials
Elastomers · Silicone · Specialty Films · Barrier Films · Laminates · Medical-Grade Polymers
Company details
- Location
- Apex, North Carolina
- Founded
- 1991
- Production volume
- Prototype to full-scale production
- Certifications
- ISO 13485:2016, ISO 9001:2015, FDA Registered (QSR 21, CFR Part 820)
- Listed under
Frequently asked questions
Where is Polyzen LLC located?
Polyzen LLC is located at 1041 Classic Rd, Apex, NC 27539, United States.
What does Polyzen LLC do?
Polyzen LLC is listed under Medical Device Manufacturers, and its listed capabilities and products include Polymer material formulation and consultation, Specialty film extrusion, Barrier films and laminates, Dip molding and coating, Coatings for stents, wires, and instruments and Low-pressure compliant balloon manufacturing.
What industries does Polyzen LLC serve?
Polyzen LLC lists Medical Devices and Life Sciences among the industries it serves.
What certifications does Polyzen LLC have?
Certifications on file for Polyzen LLC: ISO 13485:2016, ISO 9001:2015 and FDA Registered (QSR 21, CFR Part 820).
When was Polyzen LLC founded?
Polyzen LLC was founded in 1991.
How do I request a quote from Polyzen LLC?
Use the Request a quote button on this page to send Polyzen LLC your requirements through FirmsLedger, or call (919) 319-9599 and visit polyzen.com.
What companies are similar to Polyzen LLC?
Other Medical Device Manufacturers in North Carolina listed on FirmsLedger include RAUMEDIC, Global Bridge Pharmaceutical and Patton's Medical.