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LTR 165: Managing Characteristics Related to Safety
Summary
“If we don’t have connections and linkages in our risk management file from top to bottom, it’s hard to manage lifecycle risk.”
In this open discussion of the Let’s Talk Risk! conversation, host Naveen Agarwal explores a requirement in ISO 14971 that is often documented but not fully integrated into medical device risk management: characteristics related to safety.
Too often, organizations work through the questions in ISO/TR 24971 Annex A, document their answers, and file the document away. But identifying characteristics related to safety is only useful if those characteristics can…
The skinny
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