Importance of Risk Communication and Risk Analysis in Medical Device Industry

Abstract

In medical device industry the risk management plays a very vital role. There should be proper communication from each and every stakeholder related to risk management of each respective department, it can be Production, Design and Development or Quality Control and all other  departments. In this current research work the role of risk analysis which   had been done accordingly ISO 14971 for risk management of medical device using FMEA is implemented. FMEA (Failure Mode and Effects Analysis) plays important role in risk analysis by having several steps for mitigation of risk. Also it had been used for identifying hazard of each risk throughout the lifecycle of the medical device. Risk communication should be advanced so, that the risk identified can be easily controlled by taking appropriate risk control measures. In any medical device industry risk analysis should be done properly and as well the risk communication channel should be strong for proper and immediate action. In this research paper practically the role of Risk communication and risk analysis is covered. Risk management of any of the organization can only be effective if the risk analysis is done strongly and the communication related to risk is proper. In this research    FMEA analysis for risk analysis is done on a medical device and also the communication from risk manager to the other entire stakeholders of the risk management from various departments are fully taken into the consideration.