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.
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.
Speaker
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.
Who Should Attend
- 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
