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What can be categorized as a minor injury, and what can be considered a serious injury?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

For the purposes of this document, the term minor injury is used to mean any injury that does not meet the definition of a serious injury. This regulation defines serious injury as an injury or illness that:

  • is life threatening;
  • results in permanent impairment of a body function or permanent damage to a body structure; or
  • necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

For the purposes of this document, the term permanent is defined as “irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.”

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