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What are device trials?

device trials
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What are device trials?

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Medical device studies are conducted in order to further evaluate the safety and effectiveness of a device or to test new devices that have not been previously studied in a particular population. The Association for the Advancement of Medical Instrumentation (AAMI) has developed a set of voluntary product standards and recommended practices intended to respond to clinical needs and ensure patient safety. Many medical device manufacturers elect to utilize these standards to evaluate the safety and efficacy of their instrument.

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