NEWS RELEASE: Cortland Biomedical Secures FDA Registration, Expanding Role as a Trusted Contract Manufacturer for Medical Device OEMs
Cortland, New York – Cortland Biomedical, a full-service biomedical textile product development partner that provides access to a full spectrum of global engineering, design, and manufacturing capabilities, is proud to announce its FDA registration, marking a significant milestone in the company’s evolution. This new designation positions Cortland Biomedical as a full-service contract manufacturer and reinforces the company’s unwavering commitment to delivering the highest standards of quality, compliance, and service to its medical device customers.
As an FDA-registered contract manufacturer, Cortland Biomedical will better support its clients in highly regulated markets, particularly in the orthopedic sector, 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.
“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.”
With extensive expertise in the design and production of advanced biomedical textiles, 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 now partner with OEMs from initial concept through full-scale manufacturing, providing a seamless, forward-integrated approach to medical device development.
For more information about Cortland Biomedical and its expanded capabilities as an FDA-registered contract manufacturer, visit cortlandbiomedical.com or come see the team in booth 2127 at the upcoming MD&M West show in Anaheim, CA.
About Cortland Biomedical
Cortland Biomedical custom designs and manufactures high-performance biomedical textile structures leveraging years of experience in medical textile engineering methods including knitting, braiding and weaving. Its thoughtful design concepts challenge the status quo. Cortland Biomedical’s unique combination of advanced equipment and technology, a seasoned medical textile-specific engineering team, and first-rate R&D capabilities allows it to tackle customers’ complex challenges with the innovation and agility expected in the medical device industry.
Learn more at cortlandbiomedical.com.
The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
