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Concept pages explain architecture and rationale. For task-focused workflows, see the How-To Guides.

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Solution Architecture

  • Medical Device Safety Solution Overview — What the solution is, what it replaces, how Nextedy Risksheet and Powersheet work together inside Polarion ALM to deliver ISO 14971 compliance.
  • ISO 14971 Risk Management Coverage — Clause-by-clause mapping of ISO 14971:2019 to solution features, including risk analysis, risk evaluation, risk control, residual risk, and benefit-risk analysis.

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Risk Analysis Methods

  • Dual Risk Methodology: HARA and DFMEA — Why the solution supports two parallel risk analysis methods (ISO 14971 HARA and AIAG VDA DFMEA), how they differ, and how they cross-reference each other.

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Data Architecture

  • Data Model and Work Item Types — The 16 work item types, 18 link roles, and how they form the traceability graph connecting requirements, risks, and verification.
  • V-Model Traceability Chain — The decomposition path (user needs to design requirements) and the integration path (design verification to user need validation) that form the V-shaped traceability structure.

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Risk Assessment Models

  • Risk Matrix and P1xP2 Probability Model — The two-factor probability model (P1 hazard probability x P2 harm probability), bucketing algorithm, 5x5 acceptability matrix, and three-level risk classification.
  • IEC 60601 Hazard Taxonomy — The 4-level cascading hazard classification system (Energy > Electrical/Mechanical/Thermal > specific types) aligned with IEC 60601 electrical safety requirements.

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System Structure

  • System Element Hierarchy — The 5-level product decomposition (System > Subsystem > Assembly > Subassembly > Component) and how it supports subsystem-scoped analysis.
  • ISO 14971 Risk Control Hierarchy — The three-tier control priority (inherent safety > protective measures > information for safety) and how it is enforced through the riskControlType enumeration.

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Lifecycle and Compliance

  • Benefit-Risk Analysis (Clause 7.2) — When and how to use benefit-risk analysis for residual risks that cannot be reduced further, including the decision tree from post-risk through final risk classification.
  • Risk Document Lifecycle — The document workflow (draft > in review > approved > published), signature requirements, and rework cycles for risk specification documents.