Managing The Cross Functional Team Members Essay

804 Words Dec 14th, 2015 4 Pages
A). Risk management is the systematic approach of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk. Risk Management is conducted throughout a medical device’s total product life cycle. The primary reason why a risk management should be done is because it is required by FDA, EU, and other countries laws and regulations. Product not complying with risk management requirements cannot be commercialized in certain countries that require it. A very important reason for performing risk management is that is protects the patient, customer, and the overall business from future issues.
B). The role of the cross functional team members is the most prominent in the conception of the product and explaining the value proposition.
The following are part of the cross functional team and their related responsibilities:
• Clinical engineer focuses on assessing patient severity for a given product. They also determine the possibilities of how the product can be misused, different failure modes, cause of certain adverse events and their associated probabilities and their mitigation pathways. Additionally, they also use post-market data as well as literature to support their probability of certain projected events.
• An electrical engineer focuses on the electrical circuits and their components to determine certain failure modes as well as their causes, probabilities, and their mitigation pathways. Additionally, they also…

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