Marcolin is the first manufacturer in the industry to obtain ISO 13485:2016 certification.

The ISO 13485:2016 certification regulates, at the international level, quality management systems regarding medical devices. The certification is valid for three years and was granted by DNV – a world-leading independent assurance, risk management and trust provider, pioneering provider of digital assurance solutions – in respect to the “planning, production and marketing of non-active ophthalmic medical devices, i.e., optical frames and frames with blue-light blocking lenses”.
Marcolin is the first player in the industry – among manufacturers – to have received this certification.

The ISO 13485:2016 standard aims to favor the global harmonization of the requirements imposed by the various international regulations on medical devices and provides presumption of conformity with the essential requirements of these key regulations. Compliance with the ISO 13485:2016 standard is a practical foundation for manufacturers in implementing directives and regulations on medical devices, as well as in taking on their responsibilities, demonstrating, at the same time, their great commitment to the safety and quality of the medical devices sold, in order to further protect customers and product users. A key requirement for compliance with this international standard is the company’s ability to stop the distribution of non- compliant products and to recall them from the market. Marcolin’s “Traceability Project”, which was launched by the company some time ago and which supports the continuous monitoring of the supply chain with respect to all the frames placed on the market, has played a key role in obtaining the certification.

According to this project all the sunglasses and optical frames made by Marcolin have a lasered serial number on the temple (also featured on the label of all the products, together with the manufacturing date), to allow the traceability of the frames, from manufacturing to distribution.