GELIVABLE Successfully Completes On-site Audit for ISO 13485:2016 Medical Device Quality Management System

Recently, GELIVABLE（Dongguan Gelivable Technology Co., Ltd.）successfully completed the ISO 13485:2016 Medical Device Quality Management System on-site audit conducted by Intertek, an internationally renowned third-party certification body. The audit scope covers “contract manufacturing of touch display modules and integrated electronic modules for medical equipment,” marking another international standard recognition of Gelivable’s system construction, quality management, and professional capabilities in the fields of medical displays and medical electronic manufacturing.

According to the ISO 13485:2016 On-site Audit Completion Confirmation Letter issued by Intertek, Gelivable has completed both Stage 1 and Stage 2 audits and submitted relevant improvement and corrective action plans. The audit results show that the company’s quality management system complies with the audit standards and related requirements. At present, the official certification certificate is expected to be issued in mid-June this year.

ISO 13485 is an important quality management system standard widely recognized in the global medical device industry. It not only focuses on product quality itself, but also emphasizes full-process risk control, traceability, stability, and the ability to ensure the safety of end patients. For the medical industry, this is not only a certification, but also represents a company’s sense of responsibility toward life and health.

For 18 years, Gelivable has remained focused on the fields of anti-glare glass cover plates, touch display modules, and precision electronic components, while continuously promoting the application and development of its products in the medical equipment industry. The company’s products are currently widely used in hemodialysis equipment, medical testing equipment, in vitro diagnostic equipment（IVD）, STD testing equipment, industrial medical terminals, and various professional medical systems.

Gelivable believes that the biggest difference between medical products and ordinary consumer electronics lies in the fact that they are connected to patients, doctors, and life safety. Every component, every process, and every quality control step in medical equipment may directly affect the operational stability of the equipment and the user experience of end users. Therefore, the company has always held itself to stricter standards, continuously investing in and optimizing material selection, process control, clean management, supply chain collaboration, and product reliability verification.

Although the glass cover plates, touch display modules, and related components provided by Gelivable are usually only a small part of medical equipment, the company has always believed that truly excellent manufacturing is not merely about producing components, but about supporting the reliable operation of the entire medical system.

In recent years, with the continuous growth of global medical industry demand for intelligence, human-machine interaction, telemedicine, and portable medical devices, medical equipment has also placed increasingly higher requirements on display modules, touch performance, optical performance, and structural reliability. Gelivable continues to strengthen its investment in anti-glare technology, display bonding, medical-grade material applications, and high-mix low-volume manufacturing capabilities, hoping to provide global medical equipment customers with more stable, safe, and reliable product solutions.

Gelivable’s management stated: “We have always maintained a deep sense of respect for the medical industry, because medical equipment ultimately serves patients and life itself. When customers choose us, they are not only choosing a supplier, but also choosing a partner who can cooperate stably over the long term, continuously improve, and share responsibility together.”

In the future, Gelivable will continue to uphold its business philosophy of “quality first, long-termism, and continuous improvement,” further deepen its presence in the fields of medical displays and medical electronics, continuously enhance its technical capabilities and quality management level, and create greater value for global medical equipment customers and end users.

Serving users through customers’ products and contributing to the development of humanity and society will also continue to be an important mission that GELIVABLE and KANOU Group uphold over the long term.