Risks and benefits of the investigational medical device and clinical investigation (a) Anticipated clinical benefits. (b) Anticipated adverse device effects. (c) Residual risks associated with investigational medical device, as identified in the risk analysis report. (d) Risks associated with participation in the clinical investigation. (e) Possible interactions with concomitant medical treatment ...

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 ...