Cortland Biomedical Achieves FDA Registration, Enhances Medical Device Manufacturing Capabilities

Cortland Biomedical has successfully obtained FDA registration, marking a significant advancement in its capabilities as a contract manufacturer for medical device original equipment manufacturers (OEMs). This milestone represents a strategic expansion of the company's service offerings and commitment to maintaining rigorous quality standards in the medical device manufacturing industry.

The FDA registration enables Cortland Biomedical to provide more comprehensive support to clients in highly regulated medical markets, with a particular focus on orthopedic applications. By achieving this designation alongside ISO 13486:2016 compliance, the company demonstrates its ability to operate under a robust Quality Management System that meets stringent regulatory requirements.

The company's expertise spans multiple medical sectors, including orthopedics, sports medicine, cardiovascular, robotic surgery, and general surgery. This broad capability allows Cortland Biomedical to offer end-to-end support for medical device development, from initial concept through full-scale manufacturing.

Tara Yunkunis, Senior Business Development Manager at Cortland Biomedical, emphasized the significance of this achievement, noting that the FDA registration will help customers bring innovative medical devices to market more efficiently and with greater confidence. The company leverages advanced textile engineering methods such as knitting, braiding, and weaving to create customized biomedical textile solutions.

By combining sophisticated equipment, specialized medical textile engineering expertise, and robust research and development capabilities, Cortland Biomedical is positioned to address complex challenges in medical device manufacturing. The FDA registration further validates the company's technical proficiency and commitment to innovation in the medical device industry.