Software verification and validation: The dossier should contain information on the software design and development process and evidence of the validation of the software, as used in the finished device. This information should typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It should also address all of the different hardware configurations and, where applicable, operating systems identified in the labelling. 7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide evidence of conformity with the Essential Principles related to functional safety and performance, detailed information should be contained in the dossier. (ii) The dossier should describe the study objectives, methodology, results, analysis and conclusions and document conformity with Good Laboratory Practices. The rationale (and limitations) of selecting the particular animal model should be discussed. 7.8 Stability data: If available, real-time aging data shall be submitted to support the claimed shelf life. However, if real-time data is not available, accelerated stability data shall be submitted to support the claimed shelf life. Such a provisional claimed shelf life may be approved provided that the manufacturer immediately initiates real-time stability testing to validate the proposed shelf Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. life. After completion of the real time stability analysis, real-time stability data shall be submitted in support of the claimed shelf life. 7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstrates conformity of the device with the Essential Principles that apply to it. It needs to address the elements contained in the Clinical Investigation, as specified under the Seventh Schedule. If a predicate device is available, the manufacturer needs to submit the substantial equivalence evaluation along with relevant published literature in accordance with these rules. 7.10 Post Marketing Surveillance data (Vigilance reporting): The dossier should contain the Post Marketing Surveillance or Vigilance Reporting procedures and data collected by the manufacturer encompassing the details of the complaints received and corrective and preventive actions taken for the same.