Marcolin first to receive ISO certification

Eyewear brand Marcolin has received an international certificate validating the safety and quality of medical devices sold.

The ISO 13485:2016 certification was granted by the quality assurance company DNV for three years, approving the practical standard for manufacturers for the quality of ‘planning, production and marketing of non-active ophthalmic medical devices,’ such as optical frames and frames with blue-light blocking lenses.

The company had to meet the requirement to be able to stop the distribution of non-compliant products and to recall them from the market.

Marcolin claimed to be the first manufacturer in the industry to be awarded the standard and said that its Traceability Project, which tracks frames from manufacturing to distribution using a lasered serial number on the temple, has played a key role in obtaining the certification.