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1. Briefly describe the process of medical device reporting. Show a process map. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803 2. Identify a variable of interest and the motivation for studying

1. Briefly describe the process of medical device reporting. Show a process map.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803

2. Identify a variable of interest and the motivation for studying it.

3. Develop an Ishikawa Diagram describing factors affecting the output of the process.

4. Propose good data guidelines, discuss your data collection methodology.

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