NitroFlare Udemy - How to Market Medical Devices in the U.S

Discussion in 'E-Books & Tutorials' started by mitsumi, Nov 20, 2015.

  1. mitsumi

    mitsumi Active Member

    Jun 8, 2012
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    Udemy - How to Market Medical Devices in the U.S.
    Size: 157MB | Duration: 0h 40m | Video: AVC (.mp4) 1280x720 30fps | Audio: AAC 44.1KHz 2ch
    Genre: eLearning | Level: Intermediate | Language: English

    Register with the FDA
    Understanding the FDA's regulatory system is the first objective for device manufacturers looking to sell in the U.S. The 510(k) Premarket Notification submission should be prioritized when developing a medical device. This pathway provides marketing clearance and the ability to sell your medical devices in the U.S. Before sales can occur companies have two options: 510(k) Premarket Notification (unless exempt); or Premarket Approval (PMA) approval. PMA's are resource intensive, and so 510(k)'s are the ideal submission type.




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