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 canalso 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.
Founder and Principle, SoftwareCyber510K, LLC
Nancy Knettell, Founder and Principle of SoftwareCyber510K, LLC has over 30 years in Regulatory, Software Development, and Systems Engineering experience primarily in the Medical Device industry consulting to major Medical Device and IVD companies such as Cook Medical, Johnson and Johnson, ThermoFisher Scientific, Smith and Nephew, and Genomic Health.
Involvement for Nancy, 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 others facing such life threatening events by advancing the potential for life-saving medical devices through the use of quality based software engineering systems.