At DeSia, we provide testing services with our EN ISO 17025 accredited laboratory to ensure medical devices meet regulatory requirements and maintain consistent performance throughout its lifecycle.
What We Offer
Transport Simulation Testing
We perform transport simulation tests in accordance with ASTM D4169 to replicate mechanical and environmental stresses during distribution.
- Environmental conditioning
- Vibration, drop, compression, vacuum, and concentrated impact
- Test planning and reporting aligned with product-specific distribution cycles
Packaging Integrity Testing
We assess the physical and microbiological integrity of packaging systems in line with EN ISO 11607.
- Tensile strength (ASTM F88)
- Visual inspection (ASTM F1886)
- Burst testing (ASTM F1140, ASTM F2054)
- Dye penetration leak testing (ASTM F1929)
Accelerated Aging Testing
To determine shelf life and sterile barrier performance, we conduct accelerated aging studies per ASTM F1980.
- Temperature and humidity-controlled storage
- Stability protocols adapted to product-specific material characteristics
- Statistical justification for sample selection to ensure representativeness
Do you need support with your testing process? Book your complimentary initial consultation.
