Why Stability and Performance Testing Should Be Separate for Medical Devices?

Watch this session to hear from Laura Vargas, Principal Engineering Consultant, as she explores why stability and performance testing for medical device should be conducted independently, despite long-standing industry practices.

ISO 11607-1:2019 clarifies that aging tests assess material integrity over time, independent of packaging content or size, while performance testing focuses on how well packaging withstands real-world hazards. We'll dive into the ongoing debate, why some companies have not made a change, and how to align with the new standard to ensure compliance and product safety.