ISO 13485 Accredited Experts in Diagnostic Test Kit Assembly & Fulfilment
ISO 13485 Accredited Experts in Diagnostic Test Kit Assembly & Fulfilment
We offer medical device assembly services with customised solutions tailored to your business requirements.
We specialize in bespoke medical kit assembly and comprehensive fulfilment—crafting diagnostic test kits including home-testing, clinical blood testing, genetic swabs, and more. As an ISO 13485-accredited facility, we ensure rigorous quality, regulatory compliance, and traceability across all stages—from design to dispatch .
Launch your IVD medical device with confidence. Our expert team provides end-to-end compliance and regulatory support, ensuring your product meets all international standards and is market-ready. We specialise in technical compliance, helping you maintain full regulatory alignment throughout the product lifecycle.
Our ISO 13485-certified medical kit assembly and fulfilment services combine advanced automation, complete traceability, custom lab integration, and scalable 3PL logistics. From prototype to high-volume production, we deliver a seamless, compliant, and cost-effective solution tailored to your testing needs.
Build your ideal IVD testing solution with a trusted partner in medical device compliance, assembly, and fulfilment.
Reach out to discuss tailored ISO 13485 compliant kit assembly, automation, and global fulfilment capabilities.
Let’s build your scalable solution together.
We are ISO 13485 certified for manufacturing, storing, and fulfilling medical devices. Our quality and compliance team is equipped to support your business needs and provide guidance on technical aspects. Additionally, we have a comprehensive tracking system for all products.
At our company, manufacturing devices for clients means prioritising quality, compliance, and efficiency. We begin by collaborating with clients to understand their specific requirements and design needs.
After the design is approved, our production team uses advanced techniques and cutting-edge equipment to manufacture high-quality d
At our company, manufacturing devices for clients means prioritising quality, compliance, and efficiency. We begin by collaborating with clients to understand their specific requirements and design needs.
After the design is approved, our production team uses advanced techniques and cutting-edge equipment to manufacture high-quality devices. Our quality control experts rigorously inspect and test each product throughout the process, ensuring it meets or exceeds industry standards. This thorough approach guarantees top-quality results every time.
Our in-house tech team can support your business needs by offering unique coding solutions tailored to your requirements. If you need a custom fulfilment system, our team can collaborate with yours to create a solution that fits your business. We can also send and receive data through API or FTTP systems.
We provide a complete design and print solution for your packaging needs. With a decade of experience in printing and custom solutions, our team specialises in creating bespoke products.
We stock over 10,000 diagnostic consumables, from tubes all the way to plasters. If you require a bespoke item manufactured, our team are able to guide you through the whole process.
If you require storage, our team can assist and create you an inventory system to manage your goods remotely.
Through our extensive network of postal and transportation companies, we can help you reduce shipping costs. We can send pallets from our facilities to anywhere in the UK with next-day service, or to destinations around the world with just a few clicks. Our team can assist with freight handling and ensure all documentation is correctly prepared for importing or exporting goods.
If you require support in connecting Pathology labs, our tech team can help and advise on the services that available. We offer full customised solution within any testing kits, including, Home Blood test kits, Clinical blood test solutions, DNA test kits, Health screening kits, Saliva test kits, Faecal collection test kits and many more.
Fully ISO 13485-certified process for medical device assembly
Real-time digital kit traceability (components, batch-expiry, activation)
Custom software integrations with lab IT systems (LIS/LIMS, APIs)
Custom Kit Development & Design – Work with our expert team to create tailored diagnostic kit formats, including swab kits, blood collection kits, saliva kits, and genetic testing kits. Every design is fully compliant and built for scalability.
Precision Assembly & Quality Assurance – Benefit from ISO 13485-certified, fully traceable and barcoded assembly lines. Our rigorous quality control process includes double audits for sealing, packaging integrity, and temperature regulation to ensure maximum reliability.
Integrated Data & Lab Connectivity – Streamline operations with secure APIs for laboratory pairing, activation code management, automated label printing, and real-time dashboards for order tracking, returns, and performance monitoring.
Digital Transparency — Client portal for tracking orders, inventory, and delivery.
Robust Inventory Control — Track consumables with expiry alerts and batch tracking.
Fast Dispatch & Global Reach — Next-day UK shipping; scalable international options; 3PL logistics network.
We specialise in providing ISO 13485-compliant clinical test kits designed for hospitals, clinics, and laboratories.
Nexus biolink
Nexus biolink, Cleton Business Park, DY4 7TR
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