Im working on a global health writing question and need an explanation and answer to help me learn.
Choose a specific medical device that is on the market. For the particular device chosen provide
the following information:
1. List at least 4 design inputs
2. List at least 4 design outputs
3. Provide the intended use
4. Provide the indications for use
For each design input list a deliverable (i.e., plan, protocol, report, etc.).
For each design output list a deliverable (i.e., report, labeling, risk assessment document, etc.).
Provide a trace matrix for the device you have chosen based on the items listed above. The trace
matrix should be in table format.
You should be able to provide the first two items based on the type of medical device chosen.
For example, you have chosen a heart valve as your medical device. The heart valve has certain
dimensions and is made out of a polymer material. A design input requirement is the overall
length of the heart value must be 2 inches long. Another design input requirement is that the
polymer material must be ¼ inch in thickness. The output for both could be drawings.
You can find information on the FDA website and the manufacturers product website. You may
need to make some educated guesses regarding design input.
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