San Diego-based nanoComposix announces the expansion of its quality management system (QMS) to include ISO 13485:2016 certification. The certification demonstrates that the nanoComposix QMS satisfies the current industry standard for medical devices and device components. 

ISO 13485:2016 is an internationally recognized standard for medical device quality management systems. One of the benefits of the system is to ensure a company’s practices continue to meet customer and regulatory requirements throughout the lifecycle of its medical device products and components. There is a considerable investment in implementing and maintaining such systems, but the payoff is twofold; customers can be confident that products are processed in a “Quality/Continuous Improvement” environment, and the QMS makes the business run better in many ways, nanoComposix officials say.

“While we have always held ourselves to a high standard for our products and processes, we now have the formal recognition of the effort of our teams to adhere to our QMS,” adds Jennifer Lindham, quality assurance Supervisor at nanoComposix. “We look forward to continuing to provide high-quality services and products and are excited to see what new opportunities and collaborations this may bring us.”

nanoComposix is certified by Perry Johnson Registrars of Troy, Mich., which is an accredited body and an ISO registrar. “We believe that this registration is important to the industries we serve and adds value to the products we can deliver to our end customers,” says Rondii Lynberg, nanoComposix director of quality assurance and regulatory affairs. “As a company, we thank the customers, partners, colleagues, and suppliers who have helped and supported this process.”