Published On:
October 15, 2024
Why Stability and Performance Testing Should Be Separate for Medical Devices
Come learn why, in spite of conventional wisdom in the industry, medical device stability and performance testing ought to be done independently. 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.