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Medical Device Engineering Specialized Studies Program University of California, Irvine, P.O. Box 6050, Irvine, CA 92612-6050 www.extension.uci.edu UC Irvine Extension Medical Device Engineering Specialized
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What is medical device engineering specialized?
Medical device engineering specialization refers to the specialized field of engineering that focuses on the design, development, and manufacturing of medical devices.
Who is required to file medical device engineering specialized?
Manufacturers, importers, and distributors of medical devices are required to file medical device engineering specialized.
How to fill out medical device engineering specialized?
To fill out medical device engineering specialized, manufacturers, importers, and distributors need to provide detailed information about the design, materials, manufacturing processes, and performance of the medical devices they are involved with.
What is the purpose of medical device engineering specialized?
The purpose of medical device engineering specialized is to ensure that medical devices meet regulatory requirements, are safe and effective for use, and do not pose any risk to patients or users.
What information must be reported on medical device engineering specialized?
The information that must be reported on medical device engineering specialized includes details about the device classification, risk assessment, design verification and validation, sterilization methods, quality management systems, clinical evaluation, and post-market surveillance.
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