We are now ISO 13485 Certified!

Nye Lubricants, Inc. is proud to announce the achievement of ISO 13485 Certification, demonstrating our commitment to the success of our medical industry customers. Our process controls, documentation, and quality standards now meet or exceed all ISO 13485 requirements.

This certification will guide the design, development and production process of Nye’s carefully engineered and customized products, such as damping gels or greases. While serving a variety of roles, these products are specifically offered for motion, noise and haptic control in sensitive medical equipment and devices, including those designed for the parenteral delivery of drugs. Nye works closely with device design firms, contract manufacturers, and drug marketers to create products which help optimize performance, quality and cost, as well as patient compliance and safety.

The Quality team at Nye implemented and maintained the quality management system for an internal audit, which then led to final certification of ISO 13485. Nye is one of the few lubricant companies to achieve this certification. We offer the widest array of formulation chemistries, which in return helps ensure compatibility with the various plastics, elastomers and metals used in the industry.

Nye celebrates this opportunity to broaden its involvement in the technically demanding global Medical market.