How ISO-13485 Kitting Strengthens Courier Performance Across Europe

By Adri Sijben, Director of Business Development, BioTouch Europe 

Quality and logistics are deeply connected — especially in the life-science world. As we continue to scale BioTouch’s operations in Europe, I’m excited to share how our ISO-13485–certified kitting processes are not just a compliance checkbox, but a powerful lever to strengthen courier performance, reduce risk, and drive seamless European expansion. 

The Strategic Advantage of Our European Hub 

At the heart of our European growth is our 90,000 sq ft facility in Shannon, Ireland, which serves as BioTouch Europe’s headquarters. This site is ISO 13485:2016 certified, temperature monitored and strategically located with direct access to Shannon Airport and all major carriers.  

Being so well-connected allows us to deliver next-business-day into many parts of Europe and extend our reach to more than 120 countries globally.  

Why ISO-13485 Kitting Matters for Courier Performance 

1. Traceability and Validated Workflows 

Our Shannon facility is not only certified but built for precision. Every component in each kit has batch-level traceability, and we use validated workflows — minimizing human error and ensuring consistency across production.  

This level of control gives us confidence that kits are assembled correctly, every time — which significantly reduces the chances of missing or incorrect items that could lead to courier delays or returns. 

2. Temperature-Controlled Packaging Aligned with Courier Operations

Many life-science kits include temperature-sensitive materials. Our kitting operations integrate seamlessly with our temperature-control logistics capabilities.  

We use vacuum-insulated packaging (VIP), both active and passive solutions, and real-time data logging to monitor temperature throughout transit.  

For courier routes, this means reduced risk of temperature excursions, fewer rejected shipments, and more predictable delivery performance. 

3. Real-Time Visibility & Command Center Integration

Once kits leave our facility, they are tracked in real time through our logistics command center. Location, temperature, and status are monitored, so we can quickly intervene if any exception is detected.  

This proactive monitoring helps reduce disruptions, prevents damage, and ensures the courier network operates as smoothly as possible.

4. Regulatory and Customs Expertise

Navigating the regulatory landscape in Europe — including IVDR, CE marking, customs, and VAT — can be complex. At BioTouch Europe, our European team understands these challenges well and offers end-to-end regulatory support.  

This reduces risk in cross-border shipments, lowers administrative burden, and makes courier handoffs more reliable, especially at customs nodes. 

Business Continuity & Risk Mitigation 

Expanding in Europe isn't just about growth — it's about resilience. With our ISO-13485 kitting and integrated logistics, we build in redundancies: 

• Temperature-controlled inventory and packaging 
• 24/7 command center monitoring 
• Strong relationships with multiple carriers 
• A facility designed for scalable operations.  
• These capabilities help ensure business continuity. If markets shift or volumes change, we can adapt without sacrificing quality or delivery performance. 

Real-World Impact: What This Means for Our Customers 

When you partner with BioTouch Europe, you're not just getting a logistics vendor — you're getting a quality-first, compliance-driven, and highly efficient platform to expand in Europe. 

• Faster go-to-market in EU countries 
• Lower risk of shipment failures 
• Improved control over pre-analytical kit integrity 
• Scalable, trustworthy operations as your business grows 

Looking Ahead: Building Europe’s Future with BioTouch 

As Director of Business Development for Europe, I see enormous opportunity in helping life-science and diagnostics companies scale across the EU without the traditional headaches of cross-border quality and compliance. Our facility in Shannon is more than just a hub — it’s a gateway that combines quality, speed, and regulatory expertise. 

I’d love to connect if you’re evaluating European expansion or want to explore how our ISO-13485 kitting + courier model could support your business. Let’s build your European success story.