7.0 Verification and validation of the medical device 7.1 General: (A) The dossier should contain product verification and validation documentation. The dossier should summarize the results of verification and validation studies undertaken to demonstrate conformity of the device with the essential principles that apply to it. Such information would typically cover wherever applicable: (a) engineering tests; (b) laboratory tests; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India (c) simulated use testing; (d) any animal tests for demonstrating feasibility or proof of concept of the finished device; (e) any published literature regarding the device or substantially similar devices.