How medical device risk management is connected with design controls

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Medical device design controls play an important role when it comes to risk management, but the relationship isn’t always immediately clear.

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.

Listen to the full podcast on our sister site Medical Design & Outsourcing.

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