Menicon SC News

Menicon SC achieves ISO 13485 certification

Written by Menicon | Feb 7, 2025 3:00:00 AM

 

Menicon SC GmbH is pleased to announce that it has successfully achieved certification according to the ISO 13485:2016 standard. This internationally recognised standard for quality management systems of medical devices reaffirms our commitment to the highest quality standards and the continuous improvement of our products and services.

ISO 13485:2016 sets out strict requirements for the quality management system of companies that develop, manufacture and distribute medical devices. By obtaining this certification, Menicon SC emphasises its compliance with regulatory requirements. It thus meets its requirements to optimise the supply chain from A to Z in its processes and to provide its customers with an excellent delivery performance.

"Certification in accordance with ISO 13485:2016 is a significant step for our company," says Nikolaos Balauras, Managing Director. "It underlines our commitment to sustainable quality and safety in medical technology as well as faster product availability. We are proud to show our customers and partners that we adhere to high standards."

The implementation of the quality management system according to this standard enables Menicon SC to optimise processes, minimise risks and increase customer satisfaction. In addition, the certification will help to further strengthen confidence in our products and services.

Menicon SC would like to thank all employees, partners and the certifier, DQS Medizinprodukte GmbH (dqsMED), who have contributed to this success. We are determined to maintain the highest quality standards and develop innovative solutions for medical technology in the future.