SAN DIEGO, California – nanoComposix is proud to announce successful 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. “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,” said 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 (PJR) of Troy, MI, which is an accredited body and 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,” said Rondii Lynberg, nanoComposix Director of Quality Assurance & Regulatory Affairs. “As a company, we thank the customers, partners, colleagues, and suppliers who have helped and supported this process.”
Standard: ISO 13485:2016
Certificate Number: C2021-01104
Scope: Design, Development and Manufacturing of Highly Characterized Nanomaterials for Medical Device Applications
Location: San Diego, CA
nanoComposix is a world-leading manufacturer of precisely engineered and highly characterized nanoparticles. Since 2004, they have been helping customers bring nanotechnology-enabled products to market. Their multidisciplinary technical teams provide rapid prototyping, characterization, integration, and scale-up solutions to accelerate R&D and commercialization for a wide variety of applications including biodiagnostics, topical therapeutics, nanomedicine, antimicrobial coatings, and color engineering. The company offers complete vertical integration of lateral flow assay development, including bulk production of nanoparticle reporter probes, assay development services, and high-throughput automated strip manufacturing from experts with 30+ years of experience in production of medical devices.
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