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How to Manage Risk in a World of Changing Design Control Standards

Aug. 1, 2017

How does the changing landscape of international standards overlap with design control, and how should devicemakers account for these changes in their risk management plans?

One place to start is the model for risk management developed by the International Medical Device Regulators Forum (IMDRF), said Ombu Enterprises President Dan O'Leary during a recent FDAnews webinar.  FDA investigators use this model as part of their training, he said.

About 10 percent of all FDA warning letters cite risk management deficiencies, and about 55 percent cite design controls. How devicemakers relate their activities in risk management with their activities in design controls and how those processes interact with each other is the core of any medical device manufacturing risk management plan.

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