Cortland Biomedical has successfully obtained FDA registration, marking a significant advancement in its medical device manufacturing capabilities. This milestone enables the company to provide more comprehensive services to medical device original equipment manufacturers (OEMs) across multiple specialized sectors.
The FDA registration represents a critical validation of Cortland Biomedical's quality management systems and manufacturing processes. By achieving this designation alongside ISO 13486:2016 compliance, the company demonstrates its commitment to meeting stringent regulatory standards in highly regulated medical device markets.
Specializing in advanced biomedical textile production, Cortland Biomedical offers design and manufacturing solutions for diverse medical applications, including orthopedics, sports medicine, cardiovascular, robotic surgery, and general surgical fields. The FDA registration allows the company to provide end-to-end support for medical device development, from initial concept through full-scale manufacturing.
Tara Yunkunis, Senior Business Development Manager, emphasized the significance of this achievement, noting that the registration enables more efficient and confident medical device innovation. The company's integrated approach combines advanced equipment, specialized engineering expertise, and robust research and development capabilities.
The expanded capabilities position Cortland Biomedical as a more attractive partner for medical device OEMs seeking comprehensive, compliant manufacturing solutions. By offering a seamless, forward-integrated approach to medical device development, the company can help accelerate product innovation and market entry for its clients.
With its proven expertise in textile engineering methods such as knitting, braiding, and weaving, Cortland Biomedical is well-equipped to tackle complex medical device manufacturing challenges. The FDA registration further reinforces the company's reputation as a trusted, high-quality contract manufacturer in the medical device industry.
