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Machine Learning for Risk Management

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It all started as a normal day for traders David and John (not their real names). Out of the blue, their company’s audit and compliance team called them, seeking clarifications about some of their recent trades.

ISO 14971 or FMEA: Which Should You Use?

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How Do We Uncouple Global Development From Resource Use?

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‘OSHA-Proofing’ Your Business

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Do You Trust the Food You Eat?

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How Automakers Can Think Like a Disruptor

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I t wasn’t that long ago that GM ran commercials advertising that its Oldsmobile division didn’t just produce cars for your grandfather, but also for everyone else. It was an attempt to reinvent the brand’s staid image—and it didn’t work.

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

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Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.

Fault Tree Analysis and Its Common Symbols

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The FDA Forms New Partnerships to Ensure Product Safety

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Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

Presidential Candidates Want to Bring Back Millions of Outsourced Jobs

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One of the big themes in the current presidential race is how decades of free trade have dealt a heavy blow to the U.S.

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