The full ISO 14971 process: hazard identification and analysis, severity-times-probability risk estimation, the mandatory risk control hierarchy, residual risk evaluation, and overall benefit-risk conclusions.
ISO 14971 is the harmonized standard the FDA and EU MDR both recognize as the benchmark for demonstrating that a device's risks have been systematically identified, evaluated, controlled, and monitored, and this module works through the full iterative process: hazard identification and hazard analysis specific to a device's intended use and foreseeable misuse, risk estimation scored across severity and probability of occurrence, and the risk control hierarchy that mandates inherent safety by design first, protective measures second, and information for safety — warnings and labeling — only as a last resort rather than a first response.
The module ends on residual risk evaluation and the overall benefit-risk analysis that a risk management file must ultimately support, and on how the risk management file itself is never actually closed — postmarket surveillance data, CAPA investigations, and new state-of-the-art information all feed back into the same file, which is exactly the living-document discipline ISO 14971 requires rather than a one-time exercise performed before submission.