Determining a medical device’s shelf life can be one of the more challenging aspects of a new device development program.
It’s also one of the most overlooked.
The process for establishing medical device shelf life is quite complex and involves rigorous testing. And in our view, there’s a specific strategy for developing these tests that sets medical device manufacturers up for long-term success.
In this white paper, we’ll cover:
- How shelf life is defined and the role a risk assessment plays in establishing shelf life
- How the ISO 11607-1 and -2 standards contribute to establishing shelf life
- Suggested shelf life testing procedures and testing requirements
- Our view of the ideal shelf life testing strategy
With this resource, your new device development team can reduce the testing timeline and oversee a smoother, faster product launch.