Getting a medical device to market is never simple, especially when you're juggling deadlines, managing technical files, and ensuring global regulatory compliance. Shelf life testing, while essential, can be complex. Then there is the question of timing; you may not be sure when to begin testing, how real-time and accelerated studies differ, or which conditions your packaging and materials require. Choosing the wrong temperature or protocol could mean delays, non-compliance, or even failure at regulatory review.

Within the Eurofins Medical Device Services network of laboratories, we understand the critical nature of this phase. With the largest global capacity for both accelerated and real-time shelf life studies, we possess more than 12,200 m³ (430,000 ft³) of validated stability chamber space worldwide. With decades of experience, our precision testing is aligned with ISO, ASTM, and ICH guidelines.

Whether your product is sensitive to temperatures or requires long-term monitoring, we’ll help design the right study, avoiding pitfalls like using excessive temperatures that could compromise data integrity and raise regulatory red flags.

Our environmental chambers are housed in secure, monitored facilities, integrated with validated LIMS platforms. All critical systems feature built-in redundancy, including backup power generation, to ensure uninterrupted testing.

When shelf life matters, trust the Eurofins Medical Device Services network of laboratories to deliver results that are not just reliable, but regulatory-ready.

Define your shelf life strategy with confidence.