Menicon America Inc. Achieves ISO 13485:2016 Certification, Reinforcing Commitment to Quality and Customer-Centric Growth

North Billerica, MA, July 10, 2025 — Menicon America is proud to announce it has achieved ISO 13485:2016 certification, a globally recognized standard for quality management systems specific to the medical device industry. The certification was issued by the National Quality Assurance (NQA) under certificate number 23667.

This milestone reflects Menicon America’s unwavering commitment to delivering world-class service and quality as the company continues to grow and evolve alongside eye care professionals (ECPs) and patients. The scope of the certification includes relabeling and repackaging of contact lenses as well as kit assembly using lens care product components.

"As our business rapidly expands, achieving ISO 13485 certification enables us to best support our customers with consistent, high-quality products and processes," said James Gardner, President of Menicon America, Inc. "Menicon places ECPs and patients at the center of all we do, and this certification reinforces our ability to meet the highest standards of safety, quality, and reliability in everything we deliver. I am incredibly proud of the hard work and commitment by the team at Menicon America in this certification achievement and their dedication to serve the vision care community”.