SINGLE USE MEDICAL DEVICE
MFG & CONVERTING

30,000 sqft FDA Registered Medical Device Manufacturing Facility in Gallatin, TN

With 30+ years of experience, we offer extensive knowledge in medical converting for large OEMs and start-ups. We have strong relationships with major suppliers and are engineering-focused for best-in-class solutions.

Quality Certifications

ISO 13485:2016

A quality management system standard that specifies the requirements for regulatory purposes for medical devices.
UL Registered Firm Certificate # 35765.230523
FDA

FDA Registered as a contract manufacturer to ensure the safety, efficacy, and quality of various products marketed in the United States.
cGMP

Consistent production and quality control of products, mainly in pharmaceuticals, biotech, and medical devices.
CFR 820

KX MEDICAL follows FDA regulations and has established a reliable quality system to ensure their products are safe and effective.

TRUSTED PARTNERS

Capabilities

KX Medical is versatile in its precision converting and printing capabilities, including 13" wide multi-station processes that can handle complex multi-web construction with hyper-tight tolerances. We have 9 station Delta Flex Crusaders and 7 station Delta Crusaders with 2 color inline printing. Additional technologies include water-based or UV ink processing, Cognex video-controlled registration, and on press Videojet lot coding. We also offer 16” wide, 5 color flexographic printing, slitting, and rewinding services.

Products & Markets

KX Medical manufactures a wide range of custom medical products, including Advanced Wound Care, Continuous Glucose Monitoring, Remote Patient Monitoring, PPE for Patients and Caregivers, IV Dressings, and many more. We offer a diverse range of manufacturing capabilities that cater to the unique needs of each customer we serve.