Quick Tip: Define the intended use early in the design process
Begin your design controls and risk management by defining the intended use of your medical device. It is the first step in identifying applicable hazards and hazardous situations.
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LTR 54: Start your risk analysis by first defining the intended use
“The first thing I do whenever I am starting design control or risk is that I make sure that the intended use and the indication of the device are as nailed down as they can be.”