Untitled
Solution overview, supported standards, terminology, and getting started with the Medical Device Safety Solution.
Untitled
Hazard Analysis and Risk Assessment workflows: identifying hazards, evaluating risk, assigning risk controls, and benefit-risk analysis.
Untitled
Design Failure Mode and Effects Analysis: failure modes, RPN scoring, pre/post-mitigation evaluation, and DFMEA reports.
Untitled
Regulatory compliance, document workflows, electronic signatures, traceability requirements, and audit preparation.
Quick Answers
| Question | Answer |
|---|---|
| What is risksheet? | Nextedy’s spreadsheet-like editor for risk analysis inside Polarion ALM |
| What is powersheet? | Nextedy’s Requirements Traceability Matrix editor for Polarion ALM |
| Which ISO standard does this cover? | ISO 14971:2019 — Medical devices: Application of risk management |
| How many work item types are configured? | 16 types across requirements, design, risk, testing, process, and change management |
| Where do I start? | Open the Project Home Dashboard and follow the Start Here guide |