Foxx Life Sciences Achieves ISO 13485: 2016 QMS Certification for 14th Year in a Row | HealthcareIndustry, ISO, ISO13485 and more | Foxx Life Sciences Foxx Blog blog
Every year, ISO certifications become more thorough and meticulous. Even so, Foxx Life Sciences has matched that status for the last 14 years.
Here at Foxx, safety and quality are non-negotiable and are a big focus from the ground up. Throughout our products' life cycle, our goal is to ensure quality that exceeds industry standards.
“Foxx Life Sciences is seeing huge benefits with the implementation of ISO 13485:2016 Quality Management System in our entire organization. One of the key benefits we are seeing is ‘Evidence-based decision making’ by the functional and executive management, as our system is collecting the facts and data on a continual basis which are being used to make decisions that can align better with the strategic goals and objectives of the company. We are also seeing ‘Increased employee involvement’ as ISO 13485 implementation forces all employees to look for a way to enhance the processes, work with proper documentation and control. Everyone understands their roles and they become more engaged. This results in higher operational efficiency and productivity with added benefit of enhanced customer satisfaction.” Says Senior Vice President of Global Quality & Regulatory Compliance, Syed Rehan A. Rizvi.
ISO 13485: 2016, 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. To become ISO 13485 QMS 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.
Learn more about our Quality commitment in our YouTube video here: https://www.youtube.com/watch?v=UeyTgHdFoMY
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.
