Medical Device Aging and Shelf Life

Medical devices must establish shelf life specifications that ensure consistent performance and safety. Global regulatory authorities, including FDA and EU MDR, require shelf life validation data for device approval and market clearance.

Real-time aging studies are impractical for new products due to lengthy testing timelines. Accelerated aging testing uses elevated temperature protocols to simulate years of shelf life performance in weeks, providing critical data for FDA 510(k) submissions and other regulatory approval.

We verify the performance and safety of medical devices over time.

Using both accelerated aging in climatic chambers and real-time storage under standard conditions, we evaluate function and biocompatibility in comparison to new, unaged samples. This confirms that your device remains stable, safe and effective throughout its intended shelf life.

Aging Study Testing Services

Aging Testing
End-of-Life

Aging Testing

Accelerated Aging Testing

ASTM F1980-compliant Protocols for Regulatory Submissions

Our controlled environments deliver reliable aging data that meets FDA, EU MDR and international standards.

Real-Time Aging Studies

Long-term storage studies under standard conditions provide shelf life validation data. We monitor package integrity, sterile barrier performance and device functionality over time.

End-of-Life

End-of-Life Testing

Evaluation of maximum service life for reusable medical devices through repeated reprocessing cycles. We assess biological safety and functionality throughout the complete product lifecycle to determine when devices reach end-of-life specifications.

Medical Device Shelf Life Testing & Aging Studies

Aging Testing

End-of-Life