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.

A workshop was held for 2 days from June 20 to revitalize convergence research between Yonsei Health System and Yonsei University of Engineering and to develop researchers’ technological commercialization capabilities.

The workshop was attended by 35 professors from Yonsei Health System and Yonsei University of Engineering and was organized to share cases linking research results to commercialization and discuss cooperation.

Jungmok Seo, CEO of Lynk Solutec (Professor of the Department of Electrical and Electronic Engineering at Yonsei University), introduced medical device coating technology under the theme of “Innovative Medical Devices Through Prevention of Bio-adhesion.”

Lynk Coating, developed by CEO Seo, is a patented coating technology that prevents the attachment of bio-materials such as blood, mucus, and bacteria. Unlike the existing technology, it can be applied to various materials such as glass, polymer, and plastic, and can be coated stably in complex structures, drawing attention from industry and academia.

Based on this coating technology, Lynk Solutec has released a disposable cap C.E.V. (Clear Endo Vision) to help secure vision during endoscopic surgery and is developing ureter stents that prevent crust formation and non-absorbable sutures designated as rare medical devices.

LynkSolutec, which developed nano-coating technology for medical devices, completed the CES 2024 exhibition, the world’s largest consumer electronics and IT exhibition held in Las Vegas from the 9th to the 12th.

At CES 2024, LynkSolutec announced the launch of its disposable endoscopic cap “C.E.V.” with nano-coating technology. Under the slogan “Medical Side Effects? Not in Our World,” the demonstration was conducted using 3D video and actual endoscopes. In this process, famous endoscopy companies and many medical device manufacturers wooed Lynksolutec.

In addition to operating the booth, Seo Jungmok, a CEO at LynkSolutec, attended a meeting with Seoul Mayor Oh Se-hoon as the representative of a company and talked about regulating start-ups and improving the system. Seo also held an event to introduce his company’s core technology and C.E.V., an innovation award-winning product, at the main stage of the Seoul Pavilion and the Taiwan Pavilion.

“We made many achievements through CES 2024,” said Seo, CEO of LynkSolutec. “In addition to successfully introducing our first product to overseas markets, we have secured a network that will serve as a bridgehead to advance into overseas markets,” he said. “Based on this, we plan to rapidly expand our influence to the global market.”

Meanwhile, C.E.V. is a new medical device that can block even blood, mucus, and bacteria that cannot be blocked by anti-fog agents used in existing endoscopic surgery. It won two awards at the CES 2024 Innovation Awards.

Dr. Seo Jungmok, the CEO of Lynk Solutec, was invited as an invited speaker for the Technical Sessions at the 21st International Nanotechnology Symposium in 2023.

The presentation introduced the nano coating technique, a nanoscale engineering technology applicable to biomedical applications, during the “Nanobiotechnology for Biomedical Applications” section.

Nanotechnology is currently considered a key field for overcoming various limitations and challenges in the field of biotechnology. Lynk Solutec’s development of the nano coating addresses unresolved issues in the medical field, such as blood adhesion, mucus formation, and bacterial infections, contributing to improved healthcare service quality and patient safety.

Mr. Seo Jungmok, the CEO, was invited as a speaker to the NANO 2023 conference organized by the Institute of Electrical and Electronics Engineers (IEEE). This invited lecture, titled “Development of Durable and Facile Anti-Biofouling Coating for Biomedical Implants (I),” was conducted on July 4, 2023, targeting experts in the relevant field.