Is Your Medical Device Software 510k Ready?

Date Dec 13, 2018
Time (1:00 pm to 2:00 pm)
Cost $230.00
Online
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 Seminar will describe what is the FDA is expecting in the 510K submittal and how to make sure that the documentation meets those expectations.
Why You Should Attend:
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.
Areas Covered in the Session :
  • 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

 


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