Software As a Medical Device (SaMD) New IVDR Document Requirements

This course will ensure that IVD Diagnostic companies will know exactly what documentation needs to be prepared for a 510(k) regulatory filing, specifically for the software portion of the submittal so that it will be in compliance preventing delays of the 510(k).

Nancy Knettell
Instructor:
Nancy Knettell
Duration:
60 Minutes
Product Id:
502794
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
Overview:

This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions that can result from failed unannounced audits.

This course will ensure that IVD Diagnostic companies will know exactly what documentation needs to be prepared for a 510(k) regulatory filing. 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 510(k) approval.

Why should you Attend: This course will ensure that IVD Diagnostic companies that depend on custom software to deliver their service will know exactly what documentation needs to be prepared to ensure compliance and prevent costly revenue interruptions due to failed unannounced audits as required by the new IVDR 2022 regulations.

They will also know how to ensure the documentation is prepared correctly specifically for the software portion of the submittal so that it will comply preventing delays of the 510(k) 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 510(k) to prevent this risk.

Areas Covered in the Session:

  • 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 with the latest 2022 IVDR regulations
  • Avoid potential audit risks and serious findings which can prevent a company‚Äôs ability to sell their service
  • Know what is expected to have in place for compliance for your company if you wish to prepare a 510(k) filing if you plan to sell your software
  • Ensure a faster 510(k) approval because the documentation is complete and comprehensive
  • Prevent costly time to market issues because 510(k) has been rejected completely because of software

Who Will Benefit:
  • IVD Medical Device Software Regulatory professionals
  • IVD Medical Device Software Quality Assurance Engineers
  • IVD Medical Device Software Quality Senior Management
  • IVD Medical Device Software Company Senior Management
  • IVD Medical Device Quality Engineers
  • IVD Medical Device Quality Senior Management


Speaker Profile
Nancy Knettell , Founder and Principal at SoftwareCyber510, LLC, has over 30 years in Software Development and Regulatory experience primarily in the IVD and Medical Device industry for such major IVD and medical device companies such as Genomic Health, BioRAD, Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, and Johnson and Johnson.

For Nancy, involvement in diagnostic and 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.


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