What validation is required in the Class II medical device system assessment, we have a few but feel incomplete, in order to have no loopholes, ask here!

Ethylene oxide sterilization process validation report

Process water preparation process validation report

Air purification process validation

End-of-pipe cleaning process validation

Initial packaging material validation

Initial packaging process validation

Cleaning agent cleaning process validation

Ethylene oxide sterilization compatibility validation

Expiration date validation

Transportation process validation

Clean area cleaning validation (hands, object surfaces, disinfectants, clean work clothes, etc.)