Menicon America Inc. has been awarded ISO 13485:2016 certification, which validates the company's quality management systems in compliance with international standards specifically for medical devices. The certification was granted by the National Quality Assurance under certificate number 23667 and covers relabeling and repackaging of contact lenses, as well as kit assembly using lens care product components.

According to the press release, the certification assures eyecare professionals (ECPs) that Menicon’s contact lens and lens care repackaging processes are aligned with regulatory and quality benchmarks. This development is particularly relevant as the company scales up operations and broadens its service offerings in the competitive contact lens market. 

In the press release, James Gardner, President of Menicon America, reaffirmed the company’s commitment to serving both ECPs and patients.