Does anyone have an example of a standard process flow used for the standard ISO13485 7.1? inparticular identifying product realization risk management requirements?
Does anyone have an example of a standard process flow used for the standard ISO13485 7.1? inparticular identifying product realization risk management requirements?
Attached is risk management process flow chart, prepared in accordance with clause 7.1 of ISO 13485:2003 and FDA QSR 21 CFR 820.30. Hope you will find and useful.
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