Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019

#11
Hi all, interesting, i was not aware of the ISO/TR 24971:2020 could you please tell me which additional information it provides comparing to the iso 14971?
Do you recommend to buy assess it? Thanks
Shortly speaking, it provides all those details that previously were listed in the annexes to ISO 14971:2007/2012. Guidance on how to evaluate occurrence rates, evaluate risk acceptability, overview over risk management techniques,... I personally found it quite useful as a resource alongside the standard itself and would recommend buying.
 
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