Medical Device Reporting is one of the most common FDA 483 inspection observations, we created this procedure and webinar bundle to help your complaint handling unit comply with 21 CFR 803. This webinar was hosted as a live webinar on June 9, 2016, but we are updating it, and it will be hosted live on December 14, 2023. Anyone purchasing this webinar/procedure bundle will receive a link for downloading the recordings and an invitation to the live webinar if they register before December 14, 2023.

https://medicaldeviceacademy.com/medi...

The new procedure is now 15 pages instead of 5, and we included detailed instructions on how to answer every question in FDA Form 3500. This bundle also includes a bunch of additional supporting material.

Get the training you need on eMDRs to avoid an FDA 483 for failure to comply with 21 CFR 803. You will receive the reporting procedure, future updates to the procedure, a complaint log template, supporting documentation from the US FDA, a quiz to assess training effectiveness, and a training certificate. Additional training certificates are $49/each.