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PFA: ISO 14971 Risk Management Gap Analysis



The Risk Management Gap analysis will ensure that your company is compliant with ISO 14971 by systematically analyzing and mitigating potential risks to patient safety and the overall effectiveness of the device. Rook can review your risk management system from design all the way to post market activities.

What is ISO 14971?

ISO 14971 is an international standard that specifies the requirements for medical device manufacturers to establish a risk management process. It outlines guidelines for identifying, evaluating, and managing risks associated with medical devices throughout their lifecycle.

What is Risk Assessment / Management?

Risk Assessment includes identifying hazards, assessing the associated risks, evaluating and implementing risk control measures, and monitoring the effectiveness of those measures. Usually this looks like creating a preliminary hazard analysis, design failure mode effect analysis, and other documents that rate the risks. These ratings involve severity of risk, probability of risks, and the probability of detection.

What’s included in this ISO 14971 Gap Analysis?

Rook Template ISO 14971 Gap Analysis

The Template walks you through each requirement of the ISO 14971. It ensures that you have completed management responsibilities, competence of personnel, plans, risk analysis, and other risk activities. This will ensure you are ready for an internal audit and have compliance with all documents.

Let RookQS help with your ISO 14971 Risk Management

Rook’s templates can provide you assurance that you are assessing every aspect of your medical device. These templates can look at your risk from the design, use, process, and software point of view.

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