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Labelling for Medical Device Software



  • SA
    01/08/2018 00:23
    What is the meaning of labelling a medical device software? There is "version" of the software. Does this satisfy the needs of labelling? There are user-guides for use of software. Do such user-guides need to be labelled? Are there any other pieces of medical device software that need to be "labelled"? Thanks!
  • Operon Strategist
    14/01/2019 09:46
    Medical Device Labeling, the term labeling contains all necessary information provided along with the device. Which includes; -Symbols, labels, instructions, warnings and control labels applied to the medical device by coding colour, moulding, machining or printing. -The information is shown on the medical device User Interface -Documents were given with the device like installation instructions, user manuals, as well as maintenance instructions -Details printed on the device packaging Refer this link https://www.operonstrategist.com/medical-device-labeling/
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