Kubota Vision Receives ISO 13485:2016 Certification

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Kubota Vision Inc. (Kubota Vision or the Company), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced that the company received Quality Management System - ISO 13485:2016 certification for the design and development of ophthalmic medical devices.

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Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Monday, October 18, 2021
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Tags: 
Medical Devices, Health, Pharmaceutical, Optical, Clinical Trials, View, Stargardt disease, Certification, Doctor of Philosophy, Retinitis pigmentosa, Diabetic retinopathy, OCT, Patient, Quality management system, CEO, MD, Safety, Medical device
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WASHINGTON, United States, TOKYO
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KUBOTA VISION INC.
Summary
Key Points: 
  • Kubota Vision Inc. (Kubota Vision or the Company), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced that the company received Quality Management System - ISO 13485:2016 certification for the design and development of ophthalmic medical devices.
  • Kubota Pharmaceutical group continues to pursue developing ophthalmic medical devices to satisfy unmet medical needs worldwide.
  • We are in the final stage of launching Kubota GlassTM, a wearable device for myopia management, and continue maximizing the companys value and strategically enhancing our business, said Ryo Kubota, MD, PhD, Chairman, President and CEO of Kubota Vision Inc.
    Kubota Vision Inc. is a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596) committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide.
  • https://www.kubotavision.com/ ; https://www.kubotaholdings.co.jp/en/
    Kubota Vision, the Kubota Vision logo and Kubota are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.


Kubota Vision Inc. (“Kubota Vision” or the “Company”), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced that the company received Quality Management System - ISO 13485:2016 certification for the design and development of ophthalmic medical devices. ISO 13485 is an internationally recognized safety and quality standard for medical devices. Kubota Pharmaceutical group continues to pursue developing ophthalmic medical devices to satisfy unmet medical needs worldwide.

“ISO 13485 certificate demonstrates our high standard quality system in the development of medical devices, and we are proud to be awarded this certificate. We are in the final stage of launching Kubota GlassTM, a wearable device for myopia management, and continue maximizing the company’s value and strategically enhancing our business,” said Ryo Kubota, MD, PhD, Chairman, President and CEO of Kubota Vision Inc.

About Kubota Vision Inc.

Kubota Vision Inc. is a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596) committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s development pipeline includes drug candidates for the treatment of diabetic retinopathy, Stargardt disease, and optogenetics-based gene therapy for the treatment of retinitis pigmentosa. The company is also developing a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients, and a wearable device for myopia control. https://www.kubotavision.com/; https://www.kubotaholdings.co.jp/en/

Cautionary Statements: https://www.kubotaholdings.co.jp/en/1/index.html

“Kubota Vision”, the Kubota Vision logo and “Kubota” are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.

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