Ocutech Achieves ISO 13485:2016 Certification

Medical device manufacturer demonstrates commitment to quality and regulatory compliance

Published on Mar. 4, 2026

Got story updates? Submit your updates here. ›

Ocutech, Inc., a manufacturer of low vision medical devices, has achieved ISO 13485:2016 certification, an internationally recognized standard for quality management systems in the medical device industry. The certification reinforces Ocutech's focus on quality, regulatory compliance, and patient safety in the design and production of its products.

Why it matters

ISO 13485:2016 certification is an important milestone for Ocutech, as it demonstrates the company's dedication to disciplined processes and supports its mission to deliver high-quality solutions for individuals with visual impairment. The certification may also help Ocutech engage with regulatory bodies, clinical partners, and other stakeholders who rely on documented quality system controls.

The details

To achieve the ISO 13485:2016 certification, Ocutech's systems and procedures were evaluated against the requirements of the standard, including controls related to design activities, manufacturing processes, documentation, and ongoing quality monitoring. Maintaining the certification requires continued adherence to these requirements and periodic external audits.

  • Ocutech announced the achievement of the ISO 13485:2016 certification on March 4, 2026.

The players

Ocutech, Inc.

A manufacturer of low vision medical devices, including bioptic telescope systems and visual field assistive aids, that are prescribed by eye care professionals.

Henry A. Greene, OD, FAAO

The co-founder and president of Ocutech, who has been involved in the field of low vision care for decades and has informed the company's focus on designing devices that align with the needs of low vision specialists and their patients.

Got photos? Submit your photos here. ›

What they’re saying

“Achieving ISO 13485:2016 certification is an important milestone for Ocutech. It reflects our team's dedication to disciplined processes and supports our mission to deliver high-quality solutions that help individuals with visual impairment enhance their independence.”

— Henry A. Greene, OD, FAAO, Co-founder and President of Ocutech (Globe Newswire)

What’s next

Ocutech stated that it will continue to maintain its ISO 13485:2016 certification through ongoing evaluation and continuous improvement of its quality management system.

The takeaway

Ocutech's achievement of the ISO 13485:2016 certification demonstrates the company's commitment to quality, regulatory compliance, and patient safety in the design and manufacture of its low vision medical devices. This certification may help Ocutech strengthen its relationships with regulatory bodies, clinical partners, and other stakeholders who value documented quality system controls.