Packaging validation of medical devices in Class II sterile packaging

It is not mandatory to do the test in the specified organization.

If your company has the appropriate testing equipment and conditions, you can also do it yourself.

If you remember correctly, Class II sterile should verify the package sealing, sealing strength, microbial barrier and other items. Then there is also the need to do packaging and transportation testing.

The above aspects can be done on their own, as long as your company has the appropriate conditions and relevant testing equipment have been calibrated.