Customised Assembly

to Ensure Safety, Quality, and Compliance

When you are responsible for bringing safe, effective medical devices to market, every component of your manufacturing process must meet the highest standards of precision, cleanliness, and compliance. The challenge of maintaining regulatory compliance, documenting every step for full traceability, and ensuring processes are carried out under clean-room conditions is significant—and any misstep could delay delivery, impact patient safety, or jeopardise approval.

At Eurofins Sterile Packaging, we understand these pressures. Our highly trained teams and purpose-built facilities are ready to support your goals for compliance, quality, and speed. We offer comprehensive assembly services specifically designed for sterile packaging, performed under rigorously controlled ISO Class 7 and 8 clean-room environments. Such conditions ensure contamination control at all stages. 

We pride ourselves on customised assembly solutions, including the design and support of new assembly lines for your specific medical devices. Alongside established methods of gluing, bolting and injection grouting, an ESD (Electrostatic Discharge) workspace is available for electronic components, with the possibility of new equipment being devised together. Comprehensive documentation and traceability of every assembly process and every component used is guaranteed, meeting stringent regulatory requirements. We also offer the capability to perform functional and quality testing on products after assembly, providing added assurance that devices meet performance and safety specifications.

Eurofins Sterile Packaging is dedicated to helping you navigate regulatory landscapes and deliver compliant, high-quality products with market readiness. Whether you require small-batch prototype assembly or high-volume production support, we have the flexibility, expertise, and infrastructure to deliver consistently excellent results.