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The Importance of Reviewing Medical Device Labels_Ppt

Medical device companies who wish to sell their products in their respective countries must adhere to the regulations provided by the countryu2019s regulatory bodies for labeling medical devices.

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The Importance of Reviewing Medical Device Labels_Ppt

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  1. The Importance of Reviewing Medical Device Labels

  2. 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 country’s 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 FDA’s 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.

  3. 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. • Interesting right? • Want to know more on this topic: https://bit.ly/3zUVN7I

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