Cortland Biomedical Gains FDA Registration

Cortland Biomedical, a full-service biomedical textile product development partner that provides access to a full spectrum of global engineering, design, and manufacturing capabilities, has received its FDA registration. This new designation positions Cortland Biomedical as a full-service contract manufacturer and reinforces the company’s unwavering commitment to delivering quality, compliance, and service to its customers in the medical device industry.

“FDA registration is a game-changer for Cortland Biomedical and our customers,” said Tara Yunkunis, Senior Business Development Manager, Cortland Biomedical. “This milestone underscores our dedication to maintaining world-class quality systems and compliance practices. As a contract manufacturer, we can now take a more active role in helping our customers bring innovative medical devices to market faster and with greater confidence.”  

As an FDA-registered contract manufacturer, Cortland Biomedical supports its clients in highly regulated markets, where precision and reliability are critical. The FDA registration, partnered with ISO 13486:2016 compliance, ensures that Cortland Biomedical operates under a robust Quality Management System (QMS) that meets stringent regulatory requirements, offering its customers peace of mind in the safety and performance of their devices.

Cortland Biomedical specializes in creating tailored solutions for a range of applications, including orthopedics, sports medicine, cardiovascular, robotic surgery, general surgery, and others. This expanded capability allows it to partner with OEMs from the initial concept through full-scale manufacturing, providing a seamless, forward-integrated approach to medical device development.