Is You Medical Device Software 510(k) Ready?
November 15 - 16, 2018 - Boston ON CAWebinar Compliance
info@webinarcompliance.com
Phone:1-416-915-4438 / 58
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 You 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.