Intended use is especially important, says Jon Speer, founder of Greenlight.guru (Indianapolis), which markets a cloud-based quality management software.
“If you don’t have a clear order or boundaries for conducting your risk management activities, it can be someone nebulous, somewhat overwhelming. … That’s where the intended use helps with that,” Speer said.
Design controls, user needs, risk management – they all need to be done at once. “Knowing what you need to address from a risk perspective will actually help ensure that the product that you’re designing and developing is going to be risk averse,” Speer said.