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.
Find out more from Speer in our latest MDO podcast: