Commitment to Quality
Thuasne, LLC is committed to providing innovative, trusted products that positively impact patients’ daily lives. We maintain an effective quality management system through a culture of continual improvement, compliance with applicable regulatory requirements, and exceeding our customers’ expectations. As a medical device manufacturer, our quality management system is based on the principles of ISO 13485. We stand behind the performance of our products and take pride in the dedication and expertise our team brings to their work every day.
Bakersfield
is ISO 13485:2016 Certified
Our off the shelf and custom orthotic brace manufacturing facility in Bakersfield, CA. has received ISO 13485:2016 certification, the world’s most highly respected QMS standard.
Kansas City
is ISO 13485:2016 Certified
Our orthotic Knit-Rite interfaces & socks and seamless garments manufacturing facility in Kansas City, KC. has received ISO 13485:2016 certification, the world’s most highly respected QMS standard.
Hamlet
is ISO 13485:2016 Certified
Our medical compression socks and hosiery manufacturing facility in Hamlet, NC. has received ISO 13485:2016 certification, the world’s most highly respected QMS standard.
Lantz Medical
complies with the FDA 21 CFR Part 820 Quality Management System Regulation
Our Lantz Medical Rehabilitation Splinting line of products complies with the FDA 21 CFR Part 820 Quality Management System Regulation. Lantz Medical is now officially Thuasne, LLC, the American subsidiary of the Thuasne Group.
