Covestro polycarbonate resins used for medical devices

Quality Management Requirements
Through an Integrated Management System, Covestro fulfills the requirements necessary to meet medical device manufacturers‘ regulatory needs.

Covestro is proud to be a world-scale producer of raw materials (polycarbonate resins) and to be part of the manufacturing supply chain in a wide range of applications, especially medical devices.

Covestro has implemented an Integrated Management System, which defines minimum standards and requirements globally that match internationally renowned and accepted standards. The Integrated Management System of Covestro globally applies the same standards concerning quality, environment, health and safety management. As a result, the entire production site network of Covestro is certified according to ISO 9001:2015.

Beyond that, the environmental management system standard ISO 14001 and the safety management system standard OHSAS 18001 are also certifications for most production sites.

Details about all valid management system certificates can be obtained on the website of Covestro (https://www.covestro.com).

ISO 13485 Requirements

ISO 13485 is specifying requirements for a quality management system that specifically supports medical device manufacturers and their requirements for regulatory purposes.

Since Covestro has supplied materials to the medical device industry for decades, customer specific requirements related to the medical device industry are well-known and, as far as applicable, already implemented in processes and procedures of Covestro.

Furthermore, Covestro recognizes exceeding requirements of ISO 13485:2016 and ISO 9001:2008. Focus points of ISO 13485, such as risk management and control of processes, are already part of ISO 9001:2015 requirements fulfilled by the Covestro Integrated Management System.

Covestro production sites worldwide are regularly audited by medical device manufacturers and we are proud of the positive results from those audits.

Contact

Should you have questions about ISO 9001 or ISO 13485, our quality management experts can assist you. Simply contact your representative or email us: plastics@covestro.com.

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