Cortland Biomedical has secured FDA registration, marking a significant advancement in its medical textile manufacturing capabilities. The company can now offer comprehensive contract manufacturing services to medical device OEMs with enhanced regulatory compliance and quality assurance.
The FDA registration, coupled with ISO 13486:2016 compliance, positions Cortland Biomedical to provide more robust support for clients in highly regulated medical markets. This milestone enables the company to partner with OEMs throughout the entire product development lifecycle, from initial concept to full-scale manufacturing.
Specializing in advanced biomedical textiles, Cortland Biomedical serves diverse medical sectors including orthopedics, sports medicine, cardiovascular, robotic surgery, and general surgery. The new FDA designation underscores the company's commitment to maintaining world-class quality systems and accelerating innovative medical device development.
Tara Yunkunis, Senior Business Development Manager, emphasized the registration's significance, noting that it allows the company to take a more active role in helping customers bring medical devices to market with increased confidence and efficiency.
The company's unique approach combines advanced equipment, specialized medical textile engineering expertise, and robust research and development capabilities. This comprehensive strategy enables Cortland Biomedical to address complex manufacturing challenges with the innovation and adaptability required in the medical device industry.
