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The Rise and Fall of Theranos

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What We Mean When We Talk About EvGen, Part 1

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We Need a National Conversation About Sensible Drone Laws

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Risk Management Outside Your Four Walls

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Precision Testing for MEMS Accelerometers

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Why FMEA Is <em>Not</em> ISO 14971

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HIPAA Audits Are Coming! HIPAA Audits Are Coming!

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Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.

It’s Always Better to Perform a Design of Experiments

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Researchers Develop First Widely Useful Standard for Breast MRI

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Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.

Addressing Human Factors Relating to Combination Products

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Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority.

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