FTA: Fault Tree Analysis
Fault Tree Analysis is a procedure used to search for unknown causes of known effects (in the case of medical devices, harms or hazards). It, therefore, counts as a top-down procedure in risk analysis.
Harm according to ISO 14971
A medical device can cause harm to patients, users, or third parties. The manufacturer must identify this harm to determine the device’s risks and control them. This article provides guidance on how to determine and document harm in accordance with ISO 14971 and how to use the term “harm” correctly.
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