How do medical device manufacturers build a standard-compliant risk management system in accordance with ISO 14971?

The most common question in risk projects is which method to use: FMEA, FTA, HAZOP, or several in parallel. That question falls short. Methods such as PHA, FMEA, FTA, ETA, HAZOP, or HACCP are established tools, but they are not the same as the risk analysis required by ISO 14971:2019. A failure mode from the FMEA is not yet a hazard, and a top event from the FTA is not yet a risk. Between method output and risk analysis there is almost always a separate step: the analytical translation into the logic of the standard, from the hazard through the hazardous situation to harm. This is exactly where most weaknesses arise. It is not methodological breadth but analytical coherence that determines whether the file holds up in an audit.

The right sequence protects against the expensive loops. First the risk acceptability criteria are defined and justified in the risk management plan, then risks are evaluated, not the other way around. First the method output is translated into hazards, then transferred into the Risk Management File in accordance with ISO 14971:2019, which links every risk control measure to its evidence of effectiveness in a traceable way. And the file does not end at market launch: the production and post-production phase of ISO 14971:2019 requires that field data from post-market surveillance feed back into the risk evaluation and that the overall residual risk is reassessed. Anyone who maintains this chain avoids the two findings that most often come up in the surveillance audit: untranslated method tables and an outdated, unmaintained residual risk.