(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;