Submitting 510K Software Medical Devices

 Does Not Have to Hurt! Baby


  • Know exactly what you need for software or software enabled devices to successfully submit your 510K.  
  • Help to Achieve Rapid and Successful FDA Approval of your Medical Device Software.
  • Prevent unfavorable FDA Audit of Software Quality System.   
  • Take the mystery and headache out of planning and developing regulated Medical Device Software.






Nancy Knettell will be a featured speaker in May 2-4, 2016 at the 10x Medical Device Conference, Hilton San Diego Mission Valley.

Check out the website here: 10X Medical Device Conference

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List of Essential Documents and Templates You Need for IEC EN62304 Compliancy

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