Follow these tutorials in sequence. Each one builds on the concepts from the previous page.
Tutorials
-
Install the Medical Device Safety Solution — Set up the Polarion project from the Nextedy ISO 14971 template, configure risksheet templates, and verify the installation with a test HARA document.
-
Create Your First HARA Analysis — Walk through identifying a hazard, scoring pre-mitigation risk with the P1xP2 probability model, assigning a risk control, and evaluating residual risk in the HARA risksheet.
-
The V-Model Traceability Walkthrough — Trace a single user need from requirements through design, risk analysis, risk controls, and verification test cases to understand the full traceability chain.
What You Will Learn
| Tutorial | Outcome |
|---|
| Installation | A working project with all risk templates, catalogs, and PowerSheet views configured |
| First HARA Analysis | A complete risk record with pre/post-mitigation scoring and a linked risk control |
| V-Model Walkthrough | An understanding of how all 16 work item types connect through the traceability graph |
Prerequisites
Before starting, ensure you have:
- Access to a Polarion ALM instance with Nextedy Risksheet and Powersheet licenses
- Project creation permissions (or an administrator who can create the project for you)
- Familiarity with basic Polarion navigation (documents, work items, spaces)
Next Steps
After completing these tutorials, explore the Concepts section for deeper understanding, or jump directly into the How-To Guides for task-specific workflows.
