ISO 13485 Accredited Experts in Diagnostic Test Kit Assembly & Fulfilment

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Medical Kit Assembly & Fulfilment

We offer medical device assembly services with customised solutions tailored to your business requirements. 

Medical Kitting & Fulfilment Services

Custom Medical Kit Assembly & Fulfilment

Medical Device Compliance, ISO 13485-Certified Assembly & Scalable Fulfilment Solutions

Medical Device Compliance, ISO 13485-Certified Assembly & Scalable Fulfilment Solutions



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 .

Medical Device Compliance, ISO 13485-Certified Assembly & Scalable Fulfilment Solutions

Medical Device Compliance, ISO 13485-Certified Assembly & Scalable Fulfilment Solutions

Medical Device Compliance, ISO 13485-Certified Assembly & Scalable Fulfilment Solutions

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.

Ready to elevate your testing kit operations?

Medical Device Compliance, ISO 13485-Certified Assembly & Scalable Fulfilment Solutions

Ready to elevate your testing kit operations?

 Reach out to discuss tailored ISO 13485 compliant kit assembly, automation, and global fulfilment capabilities. 


Let’s build your scalable solution together. 


hello@nexusbiolink.com 

Key benefits of working with us

Quality and Compliance

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. 

Manufacturing

  
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. 

Technology

Bespoke Printing

 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. 

Bespoke Printing

Bespoke Printing

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. 

Stock and Inventory system

Stock and Inventory system

Stock and Inventory system

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. 

Shipping

Stock and Inventory system

Stock and Inventory system

 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. 

Connecting with labs

Stock and Inventory system

Connecting with labs

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.

End-to-End Medical assemble & Fulfilment Solutions

Why?

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)

Tailored Kit Solutions & Smart Fulfilment

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.

Clinical Diagnostic Kits for Healthcare Providers

 We specialise in providing ISO 13485-compliant clinical test kits designed for hospitals, clinics, and laboratories. 

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Nexus biolink

Nexus biolink, Cleton Business Park, DY4 7TR

01902 228 000

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