Lynk Solutec, a company developing innovative medical devices based on medical device coating technology, is accelerating its entry into the global medical device market with its ISO 13485 certification.

Lynk Solutec has obtained ISO 13485 certification for the design, development, manufacturing, and sales of non-absorbable sutures and endoscopic connectors. This certification signifies that the company has facilities that produce innovative products such as the award-winning ‘Endoscopic Cap’ at CES 2024 and the scarce ‘Non-Absorbable Sutures for Ptosis,’ which have been designated as rare medical devices, all in compliance with international standards.

ISO 13485 is an international standard for medical device quality management systems, ensuring that a company meets global requirements for management and quality control from development to production of medical devices. It is known that this certification can only be obtained by meeting the stringent requirements of countries with high-quality standards such as Europe and Canada, and companies that receive this certification are considered qualified to export medical devices to major countries worldwide.

Lynk Solutec is a spin-off company from BioLogical interfaces and Sensor Systems Laboratory at Yonsei University and has developed the ‘Lynk Coating’ medical coating technology, which addresses surgical complications such as infections, inflammation, and thrombosis. Utilizing this technology, the company has introduced innovative medical devices like endoscopic caps that provide clear vision during endoscopic surgery and ureteral stents that prevent encrustation.