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Shelf-Life Testing of Medical Devices

This morning I presented a live training webinar on shelf-life testing of medical devices: https://medicaldeviceacademy.com/shel... That webinar was an updated version of one I taught last year. The updated version includes significantly more information related to shelf-life testing and the submission requirements for an FDA eSTAR. Topics included in the webinar include: 1. the need for testing of non-sterile devices for shelf-life 2. applicable FDA-recognized standards for shelf-life testing and package integrity testing 3. whether accelerated and real-time aging are required for a submission 4. how to ask the FDA questions about standards 5. testing container and closure system integrity in lieu of sterility testing 6. two guidance documents that were not included in the FDA eSTAR as a reference for shelf-life testing 7. recommended questions for an FDA pre-submission 8. special stability testing requirements for multiple use products 9. how to extend the shelf-life claims of your product