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:
IMDRF (International Medical Device Regulators Forum) provides harmonized guidance on adverse event terminology and risk classification. The 2019–2020 annexes define standardized Harm, Hazard Classification, and Hazardous Situation data that must be incorporated into your Risk Management SOP and existing risk analysis processes.
Polarion centralizes IMDRF Annex content in a single controlled repository. All Risk Analysis references that data directly — eliminating uncontrolled Excel files, manual copy-paste errors, and quasi-database spreadsheets. Changes propagate automatically across all linked risk documents.
Yes. Polarion allows incremental adoption — you can weave standardized IMDRF harm and hazard classifications into your current Risk Management posture while maintaining existing workflows. The platform supports parallel operation during transition.