ISO 14971 Wrap-Up: Sanity Check, AI Descriptions, Risk Management Plan & Report

Let's wrap up the risk management course! In the final video, we'll be using Formwork's smart features to see what we're missing in our documentation. We'll also be filling out the risk management plan and risk management report. Luckily, Formwork comes with free templates, so we can just copy-paste them and fill in the missing pieces.


Check out Formwork, our eQMS software, the most affordable compliance software for medical device documentation - it includes all the free templates (risk management plan and report) shown in the video:
https://openregulatory.com/


Links to the document templates for the risk management plan and risk management report shown in the video (note that you can also use them within Formwork, which is much easier - these are only the Microsoft Word / PDF files):

Risk management plan:
https://openregulatory.com/document_templates/risk-management-plan-and-risk-acceptance-matrix

Risk management report:
https://openregulatory.com/document_templates/risk-management-report