Shipping stability: This section should provide information on shipping stability st ...

18.0 Shipping stability: This section should provide information on shipping stabilit ...

Sterilization: (i) Where the device is supplied sterile, the dossier should contain t ...

(ii) Evidence of the ongoing revalidation of the process should also be provided. Typ ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

17.0 In use stability: This section should provide information on in use stability st ...

In use stability: This section should provide information on in use stability studies ...