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Achieving the LIMS Promise

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In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are probably sour and therefore not desirable anyway.

On My Honor

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With the morning mist still on the Hudson River and the sun just kissing the cliff tops of the New Jersey Palisade, Aaron Burr, vice president of the United States, shot and killed former Secretary of the Treasury Alexander Hamilton.

FDA Inspectional Observations Increase Focus on Qualifications, Personnel Training

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In recent years, there have been published reports of an increase in Food and Drug Administration (FDA) inspectional observations associated with training deficiencies.

Defining Quality: The FDA’s Position on Good Manufacturing Practices

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Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical products like pharmaceuticals, diagnostics, and food?

More Stringent FDA Review Processes for Medical Devices on the Horizon

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After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device in

Precise Pipetting Helps Set Standards for Molecular Diagnostics

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The molecular diagnostics industry is a relatively new territory that offers much promise for early disease detection and personalized patient care.

On-Demand Compliance Software Helps Small Medical Device Makers Compete

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Electronic Medical Device Reporting Best Practices

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The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically.

Good night and sweet dreams!

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In this case study of reverse engineering and rapid prototyping we will look at a company that developed an initial prototype of an anti-snoring device based on many years of research in the field of dentistry.

New Protocols Will Test Effects of RFID Systems on Medical Devices

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Radio frequency identification (RFID) systems are widely used for applications that include inventory management, package tracking, toll collection, passport identification, and airport luggage security.

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