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Hope Vision Co., Ltd. the First Taiwanese Manufacturer to Land MDR/QMS Certification for Silicone Hydrogel Contact Lenses
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News provided by

Hope Vision

Jul 26, 2023, 04:00 ET

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TAIPEI, July 26, 2023 /PRNewswire/ -- Hope Vision Co., Ltd., a professional manufacturing service company specializing in silicone hydrogel contact lenses, has achieved a significant milestone in the medical device industry. In April 2023, the company obtained the esteemed MDR CE marking certificate for its silicone hydrogel contact lenses, which was verified by a leading notified body. 

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Hope Vision Co., Ltd.
Hope Vision Co., Ltd.

Established in June 2017, Hope Vision has consistently demonstrated its commitment to quality and compliance. The company has implemented a comprehensive and effective compliance program, ensuring adherence to globally recognized Quality Management Systems (MDR QMS/ISO 13485/GMP). Furthermore, Hope Vision has obtained certifications from reputable regulatory bodies, including the Taiwan Food and Drug Administration (TFDA), the Health Sciences Authority of Singapore (HSA), the Ministry of Health of Vietnam (MOH), and the Ministry of Health of Indonesia (MOH).

Silicone hydrogel contact lenses are made from advanced polymer materials, providing superior elasticity and breathability compared to traditional hydrogel lenses. The development and manufacturing process of silicone hydrogel contact lenses require meticulous mastery of materials, processes, and technologies.

Since the full implementation of the Medical Device Regulation (MDR), the industry has witnessed significant changes in existing regulations, leading to improved product quality in the medical device sector.

One of Hope Vision's proudest achievements is its commitment to providing PFAS-free contact lenses to customers worldwide. PFAS, commonly known as the Forever Chemicals, have been used in the manufacturing of various everyday products, including cookware, plastics, and contact lenses, since the 1950s. However, multiple studies have raised concerns about the potential adverse effects of PFAS on the human body.

By eliminating PFAS from their contact lenses, Hope Vision demonstrates its unwavering dedication to prioritizing customer safety and environmental sustainability.

Hope Vision Co., Ltd. cordially invites esteemed manufacturers from across Europe to forge mutually beneficial collaborations. Our recently acquired MDR/QMS certification for silicone hydrogel contact lenses demonstrates our commitment to meeting the rigorous standards of the European market. Committed to delivering excellence, we prioritize customer satisfaction and endeavor to cultivate enduring partnerships based on trust and shared success. For further discussions and inquiries, interested parties are encouraged to reach out to us. Together, let us chart a visionary path for the future of vision care in Europe.

https://www.hope-vision.com/en-us
[email protected]

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