CDI Energy Products’ North American manufacturing facility has received certification for the ISO 13485:2016 quality management standard through Lloyd’s Register, the international quality management system standard for the medical industry.
ISO 13485 provides manufacturing suppliers with a comprehensive quality system for providing safe and reliable products which consistently meet customer and applicable regulatory requirements. It is designed for organisations involved in the design, production, installation, and servicing of medical devices and related services.
Dr Mehdi Hashemian, CDI’s VP of Engineering and Technology, said: “Over the years, we have designed and developed a number of products for the medical sector with high-performance thermoplastics, elastomers, and composite materials. Some of those products have been vital during the Covid-19 pandemic to support global health and safe recovery initiatives. For example, CDI has been developing superior materials to increase wear life and reduce friction and energy loss, key performance characteristics of piston cups used in crucial respiratory medical equipment like oxygen concentrators.”
CDI’s new president, Clint Metcalf, added: “This certification marks a major milestone for CDI and supports our long-term product development strategy for the global medical and healthcare sector.”