Fox Life Sciences, a Salem, New Hampshire based world leader in custom single-use systems (SUS), has received ISO 13485 Certification, which requires an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, for the ninth consecutive year.
Salem, New Hampshire – Medical device industry safety and quality standards are increasingly stringent and becoming ISO: 13485 certified is challenging. However, Foxx Life Sciences has achieved this certification every year, for the last nine years.
“It’s Foxx Life Sciences’ commitment to our customers to consistently provide quality products and through continuous improvement, deliver innovative solutions,” stated Alan Roth, Quality Manager at Fox Life Sciences.
ISO: 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016. To become ISO: 13485 certified, best practices in each step of a product’s life cycle must be demonstrated through quality management processes, including service and delivery. Strict guidelines and standards must be met and displayed as effective. Anyone interested can learn more about ISO: 13485.
“Foxx Life Sciences has had a focus on quality and innovation from day one. 2019 has been an amazing year and I am so proud of our great employees, the product line we carry and the culture we have built,” says President & CEO, Thomas Taylor.
About the Company: Located just 50 kilometers north of Boston, Foxx Life Sciences is a privately-held world leader in custom single-use systems (SUS) including tubing, bag, bottle, flask and carboy assemblies, filtration, fluid management, laboratory safety products, and lab glassware for the research, biotech, and pharmaceutical industries. In addition to the Foxx Product line, the company distributes over one thousand products from Borosil, Ami Polymer, and CPC. The company is quality-focused with ISO 13485: 2016 certified since 2010, ISO Class seven cleanrooms, and three locations. With a focus on quality (ISO 13485 since 2010) and our certified ISO Class 7 cleanrooms, Foxx is the perfect partner for your next single-use custom assembly. Foxx holds a wide variety of product patents that allow us to offer highly-competitive products for cost-sensitive projects in an extremely short timeline.
Over the past ten years, the company has launched many single-use systems, including the Autofil vacuum filtration line, EZGrip Carboys from 2.5L-75L, and a wide range of patented caps with Versacap technology. The company also produces flasks, heavy-duty vacuum bottles, and media bottles, including the EZWaste Solvent HPLC Waste System, a wide range of syringe filters, cell strainers, die-cut membranes, patented mixing technologies, and DOT tight-head containers from 10L to 60L.
More recently, Foxx launched the world’s first PP vacuum funnel with GL45mm threads. In addition, the Vactrap line of vacuum bottle systems was launched in a variety of sizes, and a new microbiology filter funnel monitor. Foxx also completed a long-term agreement with Borosil for the exclusive supply of custom, private-labeled, and Borosil labeled glassware in North America. Foxx Life Science now has over six hundred products in stock in the USA.
More information about ISO: 13485 2016 Standards can be found on the ISO website.
Name: Thomas Taylor
Address: 6 Delaware Drive, Salem, NH 03079
Email: [email protected]