Risk analysis is a tool to evaluating any risk or incident that can happen to the patients who are using medical devices. Risk identification is the important part the sooner, the risk are identified ,sooner methods or plans can be made to mitigate or avoiding the risks . Risk identification helps to identify the events in early stage which will have negative impact on product’s performance. Risk identification should be covered in number of project documents like Statement of work, work breakdown structure, budget, schedule Project team participation and face to face interaction are needed to encourage communication which are essential for effective risk identification. Effective risk identification include input from entire project team and from members outside. The objective of risk identification is identify all possible risk so that solution can be found to mitigate those risks.