An IVD manufacturer is diversifying their product portfolio into traditional medical devices. Their R&D team is develop

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An IVD manufacturer is diversifying their product portfolio
into traditional medical devices. Their R&D team is
developing a product development plan for their first traditional
medical device. When developing a medical device, which of the
following tool would be most appropriate to characterize the
process outputs vs. the design features?
Group of answer choices
A) Risk Index
B) DOE
C) FMEA