1000916 Speaker Data Sheet, Background

Also first part of:

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. They also face potential audit risk which might prevent them from selling

their approved product if they have been found to not have an IEC62304 Compliant

Software Quality System.

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 so the software portion of the submittal 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.