Medical devices often go through many changes throughout their normal product lifecycles. Whenever a device goes through one of these changes, it should also undergo a review to determine the impact the change had on the biological safety of the device. While many changes have little impact and can be justified based on the minimal risk, other changes (or a compilation of changes) could pose a serious biological safety impact and require a revalidation. This presentation will cover the questions manufacturers need to ask to determine what impact changes may bring to their devices and the testing that should be performed to measure the impact of these changes.
- How to use chemical characterization to evaluate a change
- Questions to ask to determine the biological impact of a change
- What if I am changing or adding a colorant?
- What testing do I need to repeat to demonstrate a change is safe?
- Determining the possible impact of changing to 3D printing