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  • Software as a Device: What You Need to Know About the New

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - May 17, 2013 10:00 AM
  • End Time:
  • Friday - May 17, 2013 11:00 AM
  • Location:
  • Online
  • This MDDS training will explain in detail about the recent Medical Device Data System ruling and its implications. You will learn how to determine if you are affected by the new MDDS requirements and what you can do to ensure you are compliant.

    Why Should You Attend:

    The recent Medical Device Data System (MDDS) ruling reclassifies many software products used in hospitals and other healthcare facilities as "Medical Devices" subject to existing FDA regulations. Even though the new federal regulations went into effect April 18, 2012, many companies have still not complied. Many other companies may not even be aware that they are affected.
    This webinar will provide detailed information on the ruling itself, how to determine if your company is affected; and, if you are affected, what to do to get into compliance before the FDA comes knocking on your door.
    If your company designs, develops, modifies, installs or markets software products for healthcare facilities or if you are a hospital or healthcare facility that routinely modifies software that you’ve purchased, you may be affected by this new ruling.

    Areas Covered in this Webinar:

    - Detailed analysis of the MDDS ruling.
    - Implications of the ruling and who is affected.
    - How to determine if you are affected.
    - Documenting the results of your evaluation.
    - What’s required if you are affected?
    - Planning and execution
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