San Diego, 21 October 2026. nanoComposix has completed the expansion of its Quality Management System (QMS) to include ISO 13485:2016 certification. The certification covers products within the scope of the company's ISO certification. The certificate number is C2024-00534.
The scope of the certification is custom design, development, manufacturing, and storage of nanomaterials for use in medical device applications. The location covered is San Diego, CA.
ISO 13485:2016 is an internationally recognized standard for medical device quality management systems. The system is intended to ensure a company's practices continue to meet customer and regulatory requirements throughout the lifecycle of its medical device products and components.
"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.
nanoComposix is a manufacturer of precisely engineered and highly characterized nanoparticles. Since 2004, the company has been helping customers bring nanotechnology-enabled products to market. Its technical teams provide rapid prototyping, characterization, integration, and scale-up solutions for applications including biodiagnostics, topical therapeutics, nanomedicine, antimicrobial coatings, and color engineering.
Source: nanoComposix news
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