Medical Device Software Development Training Process
Date : 13 December 2018
Time : 02 : 00 PM EST
Duration : 60 Minutes

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulatory experience primarily in the Medical Device industry working with such major medical device companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Deka Research, Becton Dickenson, and Johnson and Johnson.

For Nancy, involvement in medical device development is a personal issue as well. 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.

This course is essential for Medical Device companies interested in developing 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.

This webinar will discuss regulatory requirements for the medical device software development process and how the documentation needed for FDA submission can be developed as part of that process.

Learning Objectives

  • 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

Who Should Attend

  • 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 Software Developers
  • Medical Device Software Development Management
  • Medical Device Software Medical Device Software Regulatory professionals

  • $179.00