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Medical Devices and The Year 2000: One Hospitals Approach Rachel C. Mercado, MS Year 2000 Consultant, Alone Haven Hospital Clinical Engineer, CIRCE CorporationCORRESPONDENCE AND REPRINTS Address all
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Medical devices are instruments, apparatuses, machines, implants, or other similar articles that are intended for diagnostic or therapeutic use. The form is a document used to report information about these medical devices.
Manufacturers, distributors, and importers of medical devices are required to file the medical devices and form.
The medical devices and form can be filled out online or submitted in paper form. It requires information such as the name and description of the device, intended use, risks, etc.
The purpose of the medical devices and form is to ensure the safety and effectiveness of medical devices in the market.
Information such as device classification, manufacturing information, labeling, adverse events, etc. must be reported on the medical devices and form.
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