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 Page 110 of 248 (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. (B) Such summary information may include: (i) declaration or certificate of conformity to a recognised standard and summary of the data if no acceptance criteria are specified in the standard; (ii) declaration or certificate of conformity to a published standard that has not been recognised, supported by a rationale for its use, and summary of the data if no acceptance criteria is specified in the standard; (iii) declaration or certificate of conformity to a professional guideline, industry method, or in-house test method, supported by a rationale for its use, a description of the method used, and summary of the data in sufficient detail to allow assessment of its adequacy; (iv) a review of published literature regarding the device or substantially similar devices. (C) In addition, where applicable to the device, the dossier should contain detailed information on: (a) bio-compatibility studies data as per prescribed standards; (b) medicinal substances incorporated into the device, including compatibility of the device with the medicinal substance; (c) biological safety of devices incorporating animal or human cells, tissues or their derivatives; (d) sterilisation; (e) software verification and validation; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 111 of 248 (f) animal studies that provide direct evidence of safety and performance of the device, especially when no clinical investigation of the device was conducted; (g) clinical evidence. (D) Detailed information will describe test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions. Where no new testing has been undertaken, the dossier should incorporate a rationale for that decision, e.g. bio-compatibility testing on the identical materials was conducted when these were incorporated in a previous, legally marketed version of the device. The rationale may be incorporated into the Essential Principle checklist.