Is Your Medical Device Software 510k Ready?
December 13, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:1-416-915-4458
One of the main reasons that submitting a 510K for Software Enabled Medical Devices or Software as a Medical Device can fail to get approval by the FDA is due to deficient or missing documentation. This Seminar will describe what is the FDA is expecting in the 510K submittal and how to make sure that the documentation meets those expectations.
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