Risk Management besides mandated FDA requirements

#1
What other considerations must be considered in order to have comprehensive approach to Risk Management besides the mandated requirements from the FDA?
 
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yodon

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#2
Are you asking about product risk management (ISO 14971 is the recognized consensus standard), process-based risk management (the 'risk based thinking approach called out in 13485), or something else? What "mandated requirements" are you referring to?
 
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