Software Documentation for a Successful 510k submission

Duration: 60 Minutes
One of the main reasons that submitting a 510K for Software Enabled Medical Devices or Software as a Medical Device can fail to get approval by the FDA is due to deficient or missing documentation. This course will describe what the FDA is expecting in the 510K submittal and how to make sure that the documentation meets those expectations.
510k submission
Instructor: Nancy J. Knettell
Product ID: 509304
Objectives of the Presentation
  • Know exactly what software documentation needs to be prepared for a Class II/B/Moderate Level of Concern for the Software Portion
  • Know how to ensure the software documentation is prepared correctly specifically for the software portion of the submittal so that it will be in compliance preventing delays of the 510K approval
  • Avoid potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully
  • Know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk
  • Ensure a faster 510K approval because the documentation is complete and comprehensive
  • Prevent costly time to market issues because 510K has been rejected completely because of software
Why Should you Attend
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant.

This course will ensure that Device companies will know exactly what documentation needs to be prepared. They will also know how to ensure the documentation is prepared correctly specifically for the software portion of the submittal so that it will be in compliance preventing delays of the 510K approval.

Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk.

Who will Benefit
  • Medical Device Software Regulatory professionals
  • Medical Device Software Quality Assurance Engineers
  • Medical Device Software Quality Senior Management
  • Medical Device Software Company Senior Management
  • Medical Device Quality Engineers
  • Medical Device Quality Senior Management
  • Medical Device IT
  • Medical Device Software developers
  • Medical Device Management
  • Software validation engineers
$375
Recorded Session for one participant
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  $500.00 Training CD
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Nancy Knettell, Founder and Principal at Signet Medical Systems, LLC, has over 30 years in combined mechanical design, software development, and systems engineering experience primarily in the medical device industry as a Software Verification, Validation/Systems Engineer.

Along with her senior level management experience with cross-functional program teams for major companies such as EMC and United Technologies, Nancy has also consulted to major medical companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Applied Biosystems, Deka Research, Avedro and Hologic.

But, for Nancy, involvement in medical device development is a personal issue. Having lost her father at an early age to heart disease, she now wants to work to help other people facing such life threatening events. It is her mission to advance the potential for life-saving medical devices through the use of quality based engineering systems.
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