Labelling for Medical Device Software
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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"?
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/