Risk flowchart you won’t find in EN ISO 14971:2012

If you are concerned about marketing your devices in Europe, don’t be fooled by the flowchart in the international version of ISO 14971:2007. It is WRONG...from the perspective of European medical device regulatory requirements.
Long story short – here is a flowchart I developed based on my interpretation of the European view of medical device risk management.

Lazzara Euro RM Flow Chart