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Quality Certifications

Last updated: 31 August 2026, 10:00

Quality • Compliance • Sustainability

Quality & Sustainability You Can Trust

Foxx Life Sciences is committed to maintaining rigorous quality, environmental, workplace safety, and sustainability standards across our operations and products.

Foxx Life Sciences ISO 13485:2016 Certificate
Featured Certification

ISO 13485:2016 Certified

Foxx Life Sciences maintains an ISO 13485:2016 quality management system applicable to the design and development, sales, marketing, distribution, manufacturing, and assembly of medical-device-related products and systems.

ISO 13485:2016 Medical Device Quality Quality Management System
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Our Certifications & Sustainability Documents

Explore Foxx Life Sciences' quality, environmental, safety and sustainability documentation.

ISO
Environmental Management

ISO 14001:2015

Environmental management system documentation supporting responsible and sustainable business practices.

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ISO
Occupational Health & Safety

ISO 45001:2018

Documentation demonstrating Foxx Life Sciences' commitment to occupational health and safety management.

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ISO
Social Responsibility

ISO 26000:2010

Documentation related to social responsibility and responsible organizational practices.

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EV
Sustainability

EV Scorecard

Foxx Life Sciences' sustainability assessment and environmental performance documentation.

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CO₂
Climate & Sustainability

SBTi SME Approval

Foxx Life Sciences' approval documentation associated with the Science Based Targets initiative for small and medium-sized enterprises.

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What is ISO 13485:2016 Certification?

Safety and quality are critical in the medical device industry. Regulatory requirements continue to evolve throughout every stage of a product's life cycle, including service and delivery.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes , is an internationally recognized standard that specifies requirements for a quality management system relevant to organizations involved in the medical device industry.

ISO 13485:2016 Standard →

Learn More About ISO 13485:2016 →

Last updated on: 31 August 2026, 10:00

Frequently Asked Questions

Assess your fluid handling volumes, sterility requirements, compatibility with solvents or reagents, and workflow endpoints. Foxx’s technical support team can assist in selecting single-use 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.
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