Foxx Life Sciences Achieves ISO: 13485 Certification for Ninth Year in a Row
By Admin User
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.
Assess your fluid handling volumes, sterility requirements, compatibility with solvents or reagents, and workflow endpoints. Foxx’s technical support team can assist in selecting assemblies and filtration components suited to your process.
Biotech, pharmaceutical manufacturing, vaccine production, research laboratories, clinical development, and diagnostic centres widely use Foxx single-use systems and consumables.
Yes. With global manufacturing facilities and strict quality control, Foxx products meet regulatory requirements in major markets including the US, EU, and Asia for scientific, clinical, and manufacturing applications.
Labs should follow regulatory guidelines for sterility assurance levels, validate fluid handling pathways, perform risk assessments per relevant standards (e.g., FDA, USP), and maintain traceability documentation for audit readiness. (Industry practice)
Yes. The company’s cleanroom manufacturing and quality certifications make its products suitable for Good Manufacturing Practice (GMP) environments where sterility and documentation standards are required.
Foxx Life Sciences offers Autofil® 2, EZlabpure™ and APEX™ bottle top filters, EZlabpure™ and EZFlow syringe filters, membrane disc filters, vent filters, and cell strainers engineered for high-purity filtration in analytical labs, bioprocessing, and cell culture workflows.
Foxx stands out for its ISO-certified quality, USP Class VI materials, extensive SKU portfolio with patented designs, rapid shipment, and global manufacturing footprint, providing superior compliance, performance, and cost value.
Foxx offers custom single-use solutions and assemblies designed to meet unique workflow requirements, enabling bespoke fluid paths, connectors, and tailored assemblies to optimize specific lab processes.
Standard Foxx products typically ship within 24–48 hours, while Made-to-Order (MTO) or custom SUT assemblies generally ship in 4–6 weeks, balancing speed with tailored specifications.
Single-use systems reduce contamination risk, eliminate cleaning and sterilization validation needs, cut turnaround times, lower labour and water use, and improve overall operational efficiency.
Foxx products are manufactured under ISO 13485 quality management systems in ISO Class 7 certified cleanrooms, use USP Class VI materials, and many are FDA registered. This ensures reliability, compliance, and suitability for regulated environments.
Single-Use Technology refers to disposable fluid handling and storage assemblies used in biopharmaceutical manufacturing and labs that eliminate traditional cleaning and sterilization processes, reducing contamination risk and operational complexity.
Foxx Life Sciences provides a broad range of life science and bioprocess consumables, including single-use systems (SUS), custom tubing & bottle assemblies, filtration products, lab safety equipment, glassware, plasticware, caps & gaskets, connectors, vent filters, and stainless-steel components for research, biotech, and pharmaceutical applications.
