Marcolin has obtained ISO 13485:2016 certification, which regulates international quality management systems in the field of medical devices. The Italian eyewear manufacturer is participating in a traceability project that supports the continuous monitoring of the supply chain of the frames placed on the market using serial numbers.
As part of the traceability project, all frames for sunglasses and prescription glasses manufactured by Marcolin have a laser-engraved serial number on the temple (Image: Marcolin)
An independent expert called DNV, which also offers risk assessment and management services and is a pioneer in the development of digital security solutions, has received the three-year certification for the “development, manufacture and marketing of non-active ophthalmic medical devices, i.e. frames for viewing glasses and Frames with lenses with blue light filter" exhibited.
The ISO 13485:2016 standard aims to promote global harmonization of the requirements in the various international regulations for medical devices . Compliance with the standard provides manufacturers with a practical basis for dealing with medical device policies, regulations and liabilities, while demonstrating a clear commitment to the safety and quality of the medical devices being marketed, further protecting customers and end-users of the product, Marcolin said.
Marcolin and the "Retracing" project
A very important condition for complying with this international standard is the company's ability to stop and recall non-compliant products from the market: in this regard, for Marcolin, the "traceability project" in which the company has been involved for some time and which is the continuous Monitoring the supply chain of the frames placed on the market played a fundamental role in obtaining certification.
As part of the project, all frames for sunglasses and prescription glasses manufactured by Marcolin have a serial number laser engraved on the arm, which is also included on the label of each product along with the date of manufacture, allowing Marcolin to trace the frames from manufacture to distribution .
The certification and traceability project are part of a broader ESG (Environmental, Social, Governance) plan developed by the company, in which environmental, social and economic sustainability are among the fundamentals of Marcolin 's development strategy .