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.
“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.
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 1,000 products from Borosil, Ami Polymer, and CPC. The company is Quality focused with ISO 13485: 2016 certified since 2010, ISO Class 7 cleanrooms, and 3 locations.