CDI Energy Products announced its North American manufacturing facility has received certification to the ISO 13485:2016 quality management standard through Lloyd’s Register.
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Medical Device Individual Blue White portable oxygen cylinder to put gas for patients with respiratory disorders, woman hand try to plug in the rubber tube to tank
ISO 13485 is the international quality management system standard for the medical industry established by the International Organisation for Standardisation (ISO). ISO 13485 provides manufacturing suppliers with a comprehensive quality system for providing safe and reliable products which consistently meet customer and applicable regulatory requirements.
ISO 13485 is designed to be used by organisations involved in the design, production, installation, and servicing of medical devices and related services.
CDI’s new president, Clint Metcalf, discussed the importance of this certification to CDI’s strategic goals.
He said: “ISO 13485 certification is recognised globally by our partners, customers, and regulatory bodies alike as the medical device industry benchmark for quality. This certification marks a major milestone for CDI and supports our long-term product development strategy for the global medical and healthcare sector.”
Quality systems manager Camille Hershey said: “With every certification process and audit we undertake, we have the opportunity to thoroughly examine and verify all of our business processes to ensure compliance. With this medical certification, we reaffirm our aim to achieve best-in-class customer satisfaction, quality service and we ultimately impact customers’ ability to ensure patient safety.”
CDI’s VP of engineering and technology, Dr. Mehdi Hashemian, discussed the company’s current work in the healthcare space and shared some high points on the roadmap ahead.
Dr Hashemian 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.”
CDI has been developing 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. At the same time, CDI has invested in automation of billet manufacturing, machining, and thermoforming of said cups thus has significantly increased production capacity to better respond to increased global demand.
Hashemian added: “We are fortifying our portfolio of advanced medical-grade materials and composites that support medical, biomedical, and pharmaceutical industries and developing a new seal testing and qualification centre to support all the industries we serve.”
CDI also has objectives to expand its production capabilities and global customer deliverability through automation and other smart manufacturing upgrades.
