Medical Device Package Validation
(Including ISO 11607)
Medical device package validation incorporates package performance testing, accelerated aging, material evaluation and sterile integrity testing, all following the guidelines of ISO 11607. Westpak provides package validation services for both first articles and production devices.
Package performance testing simulates environmental hazards within a controlled laboratory environment. By performing these tests inside a laboratory, the inputs have a high degree of repeatability that yields accurate results with a high level of confidence.
Choosing the Right Tests
Westpak can provide a full range of tests to cover the most complex situations. We are experts at helping you define the appropriate tests.
Customized Test Protocols
Depending on your needs, we can assist in protocol development or provide a company specific document with a detailed test plan. Consult our experienced staff when you need answers about testing.
Accelerated Aging Calculator
The FDA requires medical device manufacturers to ensure their product is viable at the marked date of expiration. Use our Accelerated Aging Time (AAT) Calculator to determine how many days the AAT test will take to complete:
ACCELERATED AGING CALCULATOR