Results 1 to 2 of 2
  1. #1
    RossTaylor is offline Newbie
    • Member Info
      • Member Type:
      • Student or Learner
      • Native Language:
      • Abkhazian
      • Home Country:
      • Barbados
      • Current Location:
      • Albania
    Join Date
    Jun 2010
    Posts
    5
    Post Thanks / Like

    Default What does this mean?

    "The documentation that we recommend you include in a premarket submission generally
    depends on the device’s Level of Concern. For the purposes of this guidance document, Level
    of Concern refers to an estimate of the severity of injury that a device could permit or inflict,
    either directly or indirectly, on a patient or operator as a result of device failures, design flaws,
    Contains Nonbinding Recommendations
    5
    or simply by virtue of employing the device for its intended use. We recommend that you
    describe the role of the software in causing, controlling, and/or mitigating hazards that could
    result in injury to the patient or the operator, because this is also a factor in determining the
    appropriate Level of Concern for your device.
    The extent of documentation that we recommend you submit for your Software Device is
    proportional to the Level of Concern associated with the device. Level of Concern is defined
    only for use in this context and is not related to device classification (Class I, II or III) or to
    hazard or risk analysis per se."

    Can you please explain the last part, "The extent of documentation that we recommend you submit for your Software Device is
    proportional to the Level of Concern associated with the device. Level of Concern is defined
    only for use in this context and is not related to device classification (Class I, II or III) or to
    hazard or risk analysis per se.", i get a bit confused when per se is used.

    Sincerely,
    Ross

  2. #2
    SoothingDave is offline VIP Member
    • Member Info
      • Member Type:
      • Interested in Language
      • Native Language:
      • American English
      • Home Country:
      • United States
      • Current Location:
      • United States
    Join Date
    Apr 2009
    Posts
    9,500
    Post Thanks / Like

    Default Re: What does this mean?

    The worse the injury that a malfunction could inflict, the more documentation you need.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •