nanoComposix Achieves ISO13485:2016 Certification

nanoComposix has achieved ISO 13485:2016 certification of its quality management system (QMS). The certification demonstrates that the nanoComposix QMS satisfies the current industry standard for medical devices and device 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.”
 
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 is certified by Perry Johnson Registrars (PJR) of Troy, MI, 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,” 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.”

Last month, nanoComposix announced that it improved its process development for scaling up the 40 nm gold citrate particles for use in lateral flow diagnostic assays. The improved capability can expand production to at least 100 L at 20 OD, enough to support the manufacturing of 30–50 million lateral flow strips per month.

The proprietary process developed by nanoComposix ensures that the particles remain stable and have consistent size distribution, even at larger scales, for more robust and reproducible assays. High production capacity also allows for more competitive pricing, facilitates better shipping and storage logistics, decreases cost of raw material for the customers, and shortens the lead time for bulk volume orders. nanoComposix can currently offer the scaled 40 nm citrate gold as part of its standard product offering. These nanometer gold nanoparticles are delivered with nanoComposix’s famous full characterization analysis it does for smaller scales.
 
nanoComposix is a manufacturer of precisely engineered and highly characterized nanoparticles. Since 2004,it has been helping customers bring nanotechnology-enabled products to market. The firm’s 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 lateral flow assay manufacturing from experts with decades of combined experience in the production of nanoparticles and medical devices.