The verification protocol of every medical device or products has to consist of doing a test suitable for the desired purpose, then check the results. Based on the output of the test, it is decided if this product or device should move on to the next step or it requires redesigning or modifying. Any verification protocol should include: Purpose including design input, design output being verified, Rationale for the verification design, Measurable acceptance criteria, Materials required, Verification Method/Procedure. Include procedure or reference for evaluation of unexpected test results, Boundary values, must be assessed and included, Data Analysis including validity criteria, if applicable, Statistical methods with references to published
methods, if applicable, and Include method for handling exceptions and outliers.
For example pen injector:
The verification protocol checks for:
1. Flow rate
2. Injection time (i.e., time required to deliver the drug/biological product)
3. Reliability of the mechanism to deliver the drug/biological product
4. Depth of injection
4. Safety features
5. Verification for absence of leakage
6. Verification of non-coring needle (e.g., if the needle is used to puncture a
septum)
7. Needle dwell time (i.e., amount of time that the needle is in the body)
8. Chemical resistance (i.e., data to ensure that the injector and its label are not adversely affected by the recommended cleaning agents)
9. Structural testing at extreme pressure and temperature conditions
10. Force required for assembly
11. Force required to actuate the injector
12. Force required to defeat the needle shield or other safety mechanism
13. Load testing on individual components
14. Needle bond strength (i.e., force required to pull the needle off the injector)
15. Needle penetration force (i.e., force available for needle insertion)
16. Needle deflection angle that causes injector failure (note: this is important if the needle retracts after insertion)
The above tests should include testing of all safety features to ensure they perform as intended. Also, for multiple use injectors, the testing should verify the duration of repeated use.