Medical · Design Control
About this session
Learn to improve your planning and reduce risk for how adverse events might happen with great products. The IMDRF guidance from 2019 and 2020 offers prescriptive terminology and data classification that companies must incorporate into their Risk Management SOP — and into the way existing data is analyzed, scored, and calculated.
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 — with Excel files that have become quasi-databases. In this 30-minute webinar, we 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
- Analyze, Mitigate, and Verify — all within a single traceable platform
- Eliminate error-prone manual Excel processes subject to uncontrolled edits