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Device Research12 Annual Device Research & Regulatory Conference April 26 to 27, 2018 (Thursday and Friday) Miami Beach, FL Optional Conference Workshop, Wednesday, April 25, 2018 * Please see www.socra.org
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What is device research?
Device research is the process of studying, testing, and analyzing medical devices to assess their safety and effectiveness before they can be approved for use by the public.
Who is required to file device research?
Manufacturers or sponsors of medical devices are required to file device research.
How to fill out device research?
Device research can be filled out by providing information on the device, study objectives, methodology, results, and conclusions.
What is the purpose of device research?
The purpose of device research is to ensure that medical devices are safe and effective for their intended use.
What information must be reported on device research?
Information such as the device description, study protocols, data analysis, adverse events, and conclusions must be reported on device research.
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