Risk management files often ship at design freeze and quietly drift when post-market data can't flow back into design inputs. Under QMSR, that loop is now auditable. #ISO13485 #QMSR #PostMarket
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@qmsnews.bsky.socialRisk management files often ship at design freeze and quietly drift when post-market data can't flow back into design inputs. Under QMSR, that loop is now auditable. #ISO13485 #QMSR #PostMarket