UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Investigator (or Investigator(s) when there is no Principal Investigator). 2. Name and address of the medical college, hospital or other facility where the Clinical Investigation will be conducted: Education, training & experience that qualify the Investigator for the clinical investigation Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India (Attach details including medical council registration number, or any other statement(s) of qualification(s)). 3. Name and address of all clinical facilities to be used in the clinical investigation. 4. Name and address of the Ethics Committee that is responsible for approval and continuing review of the clinical investigation. 5. Names of the other members of the research team (Co-Investigators or sub-investigators) who will be assisting the Investigator in the conduct of the investigation(s). 6. Clinical Investigation Plan, Title and Clinical investigation number (if any) of the clinical investigation to be conducted by the Investigator. 7. Commitments: (i) I have reviewed the clinical investigation plan and agree that it contains all the necessary information to conduct the investigation. I will not begin the clinical investigation until all necessary Ethics Committee and regulatory approvals have been obtained. (ii) I agree to conduct the investigation in accordance with the current Clinical investigation plan. I will not implement any deviation from or changes of the Clinical investigation plan without agreement by the Sponsor and prior review and documented approval/favorable opinion from the Ethics Committee of the amendment, except where necessary to eliminate an immediate hazard(s) to the clinical investigation participant or when the change(s) involved are only logistical or administrative in nature. (iii) I agree to personally conduct and/or supervise the clinical investigation at my site. (iv) I agree to inform all Subjects that the medical devices are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent and Ethics Committee review and approval specified in this Schedule are met. (v) I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s) in accordance with the regulatory and Good Clinical practice guidelines. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (vi) I have read and understood the information in the Investigator's brochure, including the potential risks and side effects of the medical device. (vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the clinical investigation are suitably qualified and experienced and they have been informed about their obligations in meeting their commitments in the clinical investigation. (viii) I agree to maintain adequate and accurate records and to make those records available for audit/inspection by the Sponsor, Ethics Committee, Licensing Authority or their authorized representatives, in accordance with regulatory and provisions of these rules. I will fully cooperate with any clinical investigation related audit conducted by regulatory officials or authorized representatives of the Sponsor. (ix) I agree to promptly report to the Ethics Committee all changes in the CIP activities and all unanticipated problems involving risks to human Subjects or others. (x) I agree to inform all serious adverse events to the Sponsor, Central Licensing Authority as well as the Ethics Committee within forty-eight hours of their occurrence. In case of failure, I will submit the justification to the satisfaction of the Central Licensing Authority. I also agree to report the serious adverse events, after due analysis, to the Central Licensing Authority, Chairman of the Ethics Committee and head of the institution where the investigation has been conducted within fourteen days of the occurrence of serious adverse events. (xi) I will maintain confidentiality of the identification of all participating clinical investigation patients and assure security and confidentiality of clinical investigation data. (xii) I agree to comply with all other requirements, guidelines and statutory obligations as applicable to clinical Investigators participating in clinical Investigations. Date: Signature of Investigato