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One of the most common reasons that organization submitting a 510(k) for Software Enabled Medical Devices or Software as a Medical Device fail to obtain approval by the FDA is due to deficient or missing documentation. This Seminar will describe what is the FDA is expecting in the 510(k) submittal for software and how to make sure that the documentation meets those expectations to prevent costly time to market delays because of either initial denial or delays in the approval process.
Please join us for a two day seminar titled “Is Your Medical Device Software 510(k) Ready?” to learn 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 and will prevent costly delays of the 510K approval by the FDA.
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 as well.
After completing this seminar, you will gain a better understanding of the expectations FDA have for your 510(k) submission for the Software Section of the submittal.
The areas that will be discussed in the seminar will include the following topics throughout the agenda:
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