Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these same companies do not manage their project risks well.

What is project risk management?

The Guide to the Project Management Body of Knowledge (Project Management Institute, 2013) defines risk as “an uncertain event or condition that, if it occurs, has a positive or negative effect on one or more project objectives.” Therefore, project risk management is the method used on the project to manage the risk. Those activities include planning (how you are going to manage risk), identifying, analyzing, response planning, and controlling the risks on the project.

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