Reference no: EM133488050
Problem: Analysis of FSE for Medtronics Cardiovascular Devices Paper
Write a paper (including a risky business template, and the risk analysis tool of choice or FEMA template using the risk management terminology, process, and methods to evaluate the following (Your own case study) for this assignment.
A summary of the company, product, intended use, and patient condition and population.
The evaluation of the 2-3 FSE through risk analysis for the use and the design of the products or a process, focusing on the failure modes and causes using tools like FMEA/FTA/HACCP. Include at least five failure modes and appropriate associated causes for each hazardous situation.
Add controls failure modes and causes. Ensure you are considering inherent safety by design, protective measures, and / or information as your control options.
Evaluate which of the failure modes are most important and if the controls are effective.