Attributes of a good risk management report

Risk management report is used to document a summary of risk management activities.
It is one of the most important documents in your risk management file because it provides an evidence of the risk management review per the requirements of ISO 14971.
More importantly, the risk management report is reviewed by outside parties such as regulators and notified body auditors. It must provide a clear, conclusive evidence of the acceptability of the overall residual risk in the context of the benefits of the intended use.
This video offers tips for writing a good risk management report.
👉Subscribe to the Let's Talk Risk! newsletter naveenagarwalp...
👉Connect on LinkedIn / naveenagarwal

[@donyapanahpouri]

Tnx for sharing this video

[@andywidholm4595]

Thank you so much for what you do!

[@ngn6576]

What FDA worksheet was shared?