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Which of the following are reasons that a medical device manufacturer would incorporate commercial off-the-shelf (COTS) software with a new medical device? Check all that apply.

A. The manufacturer would have more complete version control of the software and more control of the product’s life cycle.
B. The cost of development would be lower.
C. The manufacturer could focus resources on device-specific functions and applications.
D. COTS software is not regulated.



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