YESight Medical Secures ISO 13485 Certification, Accelerating Global Expansion with Yetsea Ultra-Widefield Scanning Laser Ophthalmoscope
Yesight
Ophthalmic Medical Device R&D and Manufacturer
Recently, Yaoshi (Suzhou) Medical Technology Co., Ltd. ("Yesight"), a company within Medpark, has officially passed the rigorous audit by an international authoritative certification body and successfully obtained the ISO 13485:2016 Medical Device Quality Management System certification. This signifies that Yesight's quality management system, covering the entire process of research and development, production, sales, and service, fully complies with international standards. It provides international endorsement for the outstanding quality of the company’s core product, the "Yesight StellarSea" laser scanning ophthalmoscope, and lays a solid foundation for the global market expansion of its products.
International "Passport"
Illuminate the Path of Global Strategy
ISO 13485 is an internationally recognized, comprehensive quality management system standard specifically for the medical device industry, and is a key "passport" for products entering overseas markets such as the EU, Canada, and Australia.
The passing of this certification is an important milestone in Yesight's globalization strategy. It is like a highly valuable "international passport," which can not only significantly enhance the trust of international clients and partners in the company but also pave the way for compliance, enabling core products such as the "StellarSea" laser scanning ophthalmoscope to more smoothly serve the global market and empower precise diagnosis and treatment.
Single-shot imaging with a 168-degree ultra-wide angle range
'Yetsea100 Ultra-Wide SLO by Yesight' adopts advanced ultra-wide-angle imaging technology, with a field of view reaching an unprecedented 168 degrees. Compared to traditional ophthalmoscopes, the ultra-wide field of view can capture more retinal details at once, which is highly significant for detecting peripheral retinopathy and minute vascular abnormalities. Doctors are able to observe fundus structures more comprehensively and meticulously, thus improving diagnostic accuracy and efficiency.
One-Touch Fully Automatic, Ultra-Widefield Fundus Examination Easily Completed
'Yetsea100 Ultra-Wide Angle SLO by Yesight' integrates advanced auto-focus, precise positioning, and rapid scanning technology. With a single button operation, it automatically completes the entire examination process, completely revolutionizing the cumbersome manual adjustments required in traditional fundus examinations. This not only significantly improves examination efficiency but also reduces the workload of medical staff, ensuring every examination is completed in the shortest possible time, providing a more comfortable experience for patients.
Four-laser Confocal Imaging Platform
For the first time in China, the integration of four laser wavelengths (487nm/520nm/660nm/785nm) in confocal laser technology has been achieved. By precisely controlling the scanning paths of the four lasers, it enables accurate capturing of different depths of the fundus. Compared with traditional imaging technologies, four-laser confocal imaging offers higher resolution and deeper imaging depth, clearly presenting the detailed structures of each layer of the fundus.
A New Starting Point with Certification
Practice the Mission of Eye Health
This certification is by no means an overnight achievement, but rather the inevitable result of the company's long-term dedication to building a systematic, procedural, and risk-controllable quality management system. Looking ahead, Yesight will seize this opportunity to continue upholding its mission of "bringing brightness and hope to every pair of eyes." Supported by a robust quality management system, the company will accelerate the research, development, and implementation of cutting-edge ophthalmic technologies, introducing more intelligent and precise ophthalmic diagnosis and treatment solutions. By collaborating with global partners, Yesight is committed to advancing the progress of eye health initiatives, making the world clearer and brighter!
