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Brighton and Sussex University HospitalsMedical Device, Medical Equipment and Product Trials PolicyVersion:3Category and number:Was TCP 0160Approved by:Senior Management Teammate approved:21st January
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Who needs medical device medical equipment?

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Emergency responders and paramedics who require medical equipment for on-site treatment.
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Medical device medical equipment refers to tools, instruments, machines, implants, or in vitro reagents that are intended for use in the diagnosis, treatment, monitoring, or prevention of diseases or other medical conditions.
Manufacturers, importers, and distributors of medical device medical equipment are required to file the necessary documentation with regulatory authorities.
The process of filling out documentation for medical device medical equipment typically involves providing detailed information about the device, including its intended use, materials used, manufacturing processes, and safety and effectiveness data.
The purpose of medical device medical equipment is to aid in the diagnosis, treatment, monitoring, or prevention of medical conditions, ultimately improving patient outcomes and quality of life.
Information that must be reported on medical device medical equipment includes device specifications, risk assessments, clinical testing data, labeling, and adverse event reporting.
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