Medical device documentation definition

Medical device documentation means paper or any other object capable of presenting a meaning through any statement relating to a medical device, which is inserted or enclosed in the container or packaging of such medical device and shall also include a manual for using such medical device;
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Medical device documentation means paper or other object which discloses a meaning by means of a statement pertaining to the medical device inserted or enclosed in the container or packaging of such medical device and shall also include the instruction manual of such medical device.
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Related to Medical device documentation

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • Product Documentation means the specific materials listed under “Documentation” at

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Software Documentation means software information, being technical information used, or useful in, or relating to the design, development, use or maintenance of any version of a software programme.

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.