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FORM FDA 3500
Therapeutic failures (product didnt work). Report SERIOUS adverse events. An event is serious when the patient outcome is: Death. Life-threatening.
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Custom Forms - ServicePRO Wiki
Mar 16, 2015 ServicePRO includes three predefined product types: Generic Product, Hardware, and Software. Failed notification: Send only failure
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the FMEA Worksheet
Identify potential failure modes and their impact on product reliability. 6, 2. Rank the potential defects to establish priority - The highest RPN value
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