Risk Hazard Analysis

What is Risk Hazard Analysis?

Risk hazard analysis is required for compliance with ISO 14971:2019 Medical Devices- Application of Risk Management to Medical Devices. This template guides users through risk analysis, evaluation, control and monitoring. This template includes:

• Drop-down options to select hazard types, harms and risk control options.
• Formulas to automatically compute risk scores, determine if risk reduction is required and if mitigations are acceptable.
• An instruction tab and example text.

3 Tips on Risk Hazard Analysis:

Risk Hazard Analysis is a critical aspect of medical device development. Below are three actionable tips to help you make progress in the right direction.

1. Ensure that your risk management plan outlines risk ratings in terms of probability of occurrence and severity of harm.
2. Maintain traceability between any design requirements generated as risk mitigations and the risk hazard matrix.
3. Conduct risk hazard analysis routinely during the development cycle to avoid any late-stage problems with intolerable risks, or risks with inadequate mitigations.