July 2, 2013

Risk Hierarchy and Risk Management Tables in Medical Device Development

Helix ALM
In working through design reviews and defining risk control measures, many teams can get bogged down in the vocabulary of harms, hazards, and causes instead of focusing on the goal of classifying and mitigating risk. Remember that the purpose of this work is to build a table or hierarchy of potential harms the device could cause, what is likely to cause them, and what measures you're going to design into the device to reduce or eliminate the chances of that harm occurring. In the following video, which is a short excerpt from our recent Leveraging Traceability in Your Risk Management Strateg webinar,  Dr. David Vogel of Intertech Engineering walks through an example of building a harm/hazard/cause hierarchy for an infusion pump. He demonstrates how that hierarchy gets converted into a risk management table and the video ends with a quick look at how TestTrack can simplify the process of building and maintaining risk controls. http://youtu.be/h6-IS-DLows