International standard IEC 60812:2018 explains how failure modes and effects analysis (FMEA) is planned, performed, documented and maintained.

FMEA (Failure Mode and Effects Analysis) is a proactive, bottom-up risk assessment methodology. Its core purpose is to:

-Identify potential failure modes of a system, product, or process (i.e., how it can fail to perform its intended functions).

-Determine the potential effects or consequences of those failures.

-Identify the potential causes of those failures.

-Evaluate the risk associated with these failure modes (often considering severity, occurrence, and detectability).

-Identify and prioritize actions to mitigate these risks.

Annex E.2 of IEC 60812 specifically addresses Software FMEA (SFMEA). Examples of software failure modes (goes beyond just "bugs"):

-Incorrect algorithm execution

-User interface (UI) malfunctions (e.g., displaying incorrect data, unresponsive controls)

-Data corruption or loss

-Failures in communication interfaces (with other devices or systems)

-Security vulnerabilities (e.g., unauthorized access, data breaches)

-Timing issues or performance degradation

-Error handling failures

-Unintended software states or behaviors

Software FMEA is a tool that can be used as part of your ISO 14971 compliance, specifically for risk analysis of software components. However, FMEA alone is generally not sufficient to meet all the requirements of ISO 14971. ISO 14971 requires a broader, top-down and bottom-up approach, considering all aspects of the medical device lifecycle and all potential hazards, not just those arising from component failures.

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