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  • Editorial Staff

Marcolin certifies the quality management system for medical devices

The company specialized in eyewear Marcolin has obtained Iso 13485: 2016 certification, which regulates quality management systems in the medical device sector at an international level. The standard, in fact, has the objective of favoring the global harmonization of the requirements required by the various international regulations for medical devices and provides a presumption of conformity with the essential requirements of these regulations.

The adoption of the ISO 13485: 2016 standard represents a practical foundation for manufacturers to address medical device directives, regulations and responsibilities, while demonstrating a clear commitment to the safety and quality of marketed medical devices, a protection of customers and end users of the product. Issued by DNV, an independent body and leading trust provider in risk assessment and management services, the three-year certification has been recognized in relation to the design, production and marketing of non-active ophthalmic medical devices, i.e. optical frames and frames with blue block lenses.

A relevant requirement for compliance with this international standard is the company's ability to block and recall from the market any non-compliant products: in this sense, for Marcolin the 'Traceability Project' in which the he company has been committed for some time and supports continuous monitoring in the supply chain of eyewear placed on the market. The project requires that all sunglasses and optical frames made by Marcolin carry a lasered serial number on the temple (also indicated on the labeling of each product, together with the manufacturing date), so as to allow the company to track the frames. from production to distribution.

Obtaining the ISO standard and the Traceability Project are part of a broader ESG plan developed by Marcolin which has one of the foundations of its development strategy in sustainability.

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