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.

Sign up to the right for your Complimentary List of Essential Documents and Templates You Need for Software 510K Submittal


Ask us about our Complete EN/IEC 62304 Fully Compliant Policy, Procedure, and Template Package.

Avoid a potential unfavorable audit. Implement a Software Quality System rapidly and to full compliance with both current US FDA and European ISO regulations.

Contact us at: or 1-978-270-5053 for more information



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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