The Importance of Reviewing Medical Device Labels

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The Importance of Reviewing Medical Device Labels
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The Challenges of Testing Artificial Intelligence
(AI)

• Medical device companies who wish to sell their
  products in their respective countries must
  adhere to the regulations provided by the
  countrys regulatory bodies for labeling medical
  devices.
• Do you know? One-third of all medical errors are
  caused by poor labeling. Labeling and packaging
  issues are the leading causes of medication
  errors. Instructions on medical devices or
  labelling are things that should be
  understandable to the user who reads them without
  any medical knowledge.
• The FDAs Center for Devices and Radiological
  Health reports that one-third of the roughly
  100,000 medical device event reports they receive
  each year are attributed to the usage error of
  the Device.
• What is Medical device labeling?
• As per the FDA , the 'display of written,
  printed, or graphic matter upon the immediate
  container of any article..' is called a "label."
  Any physician who is prescribing the device
  should be able to find the information on the
  label quickly, and any patient should be able to
  understand the information on how to use their
  medical device at home. Failure of this will lead
  to serious complications, and sometimes the
  improper usage of medical devices can even lead
  to death.

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The Challenges of Testing Artificial Intelligence
(AI)

• For Europe, UDI and EUDAMED, and to be in
  compliance with EU MDR medical device labeling,
  there are certain guidelines shared by EU
  regulatory authorities for Medical devices and EU
  MDR Compliance.
• Guidelines for Medical device labeling for Health
  Canada specify how the device should be labeled
  as per their regulations when it is released into
  the Canadian Market.
• Similarly, the Therapeutic Goods Administration,
  Australia has also specified their Medical Device
  labeling guidelines for Australia for the
  products that are being marketed in their
  country.
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• Interesting right?
• Want to know more on this topic
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