ISO 14971 risk assessment template

ISO 14971 is an international standard that outlines the process for risk management specifically for medical devices. It provides a framework for identifying, evaluating, controlling, and monitoring risks throughout a device’s entire lifecycle so manufacturers can ensure safety and regulatory compliance in global markets. This standard is widely required by regulators such as the FDA and the European Commission.

Risk management following ISO 14971 is vital because it is required by global regulators and protects both patients and businesses. Failing to conduct risk assessments can result in product recalls, regulatory action, or patient injury, which can have serious legal and financial consequences for your organization.

Hazard identification involves reviewing your device design, materials, intended use, and feedback from testing or users. Common methods include brainstorming sessions, reviewing incident reports, and consulting technical standards. This step ensures you systematically consider all possible sources of risk, even unexpected ones.

You’ll need to document your entire risk management process: hazard identification, risk estimation, evaluation, control measures, and verification of effectiveness. Regulatory agencies often ask to see your risk management file, which should provide clear evidence that you have followed ISO 14971 requirements and taken appropriate actions.