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 (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:

(Learn from some of the medical device industry’s top executives and experts at DeviceTalks Boston on Oct. 2.)


DeviceTalks West: Expertise you need to know

textadimage Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm.

From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in their own right.

Read on to discover five example of medical device expertise to be had at DeviceTalks West, which runs Dec. 11–12 in Orange County, Calif.

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