CY 21 Medical Device Webinars
About this Session: Learn to Improve your Planning and reduce your risk for how bad things might happen with great products. Analyze, Mitigate, Verify. repeat
Guidance from the IMDRF in 2019 and 2020 offers proscriptive terminology and data classification that companies will need to incorporate into their own Risk Management SOP, and the way in which existing data is analyzed, scored, and calculate. This information introduces standardized content for Harm, Hazard Classification, and Hazardous Situations that must be woven into your company’s current Risk Management posture without disruption.
For many, that means navigating a number of tools, excel documents, and manual procedures that are subject to direct text edits, and Excel files that have become quasi-databases. In this 30 minute webinar, we will show in a live demonstration how to use Polarion to:
Manage the IMDRF Annex content in one place, and have all Risk Analysis use that data
Seamlessly build these Regulatory norms into Risk Management