Category Archives: Blog content

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point. That’s the day to present a case to convince the FDA that the device—for which there’s no comparable predecessor—is safe and effective enough to be used on patients. Read more…
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Peruvian Prospects: The Medical Device Industry of a Country Founded on Precious Metals

It was a lot to take in running on about five hours of sleep following an international flight complete with a lost luggage cliché. Representatives from multiple agencies—governmental, regulatory, medical device companies, hospital purchasers, materials experts, testing laboratories, and more—were coming together in Lima, Peru, for a workshop on medical device regulation and standards. Read…
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