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What is the Medical Device Safety Solution?

The Medical Device Safety Solution is a pre-configured Polarion ALM project template that implements ISO 14971:2019 risk management for medical devices. It uses Nextedy risksheet for structured risk analysis (HARA and DFMEA) and Nextedy powersheet for requirements traceability matrix (RTM) navigation. The solution replaces Excel-based risk management with a structured, audit-ready environment that provides real-time traceability between hazards, requirements, risk controls, and verification activities.

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What standards does the solution support?

The solution primarily implements ISO 14971:2019 (Medical devices — Application of risk management to medical devices). It also aligns with:
  • IEC 60601 — Hazard taxonomy based on the IEC 60601 classification of electrical, thermal, mechanical, and other hazard types
  • IEC 62366 — Human factors support through perceptionError and cognitionError fields on failure modes
  • ISO 13485 — Quality management system support via the document workflow with electronic signatures

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What is the difference between risksheet and powersheet?

Featurerisksheetpowersheet
PurposeRisk analysis editing (HARA, DFMEA, PFMEA, Risk Control Plan)Requirements Traceability Matrix (RTM) navigation
URL pattern/risksheet?document=.../powersheet?document=...
Data typesriskRecord, failureMode, riskControluserNeed, sysReq, desReq, testCase
Key featureFormula-computed risk levels, P1xP2 probabilityV-model relationship navigation, pick constraints
Both are Nextedy products that run inside Polarion ALM. They share the same project configuration (.polarion/context.properties) but serve different roles in the risk management workflow.

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What risk analysis methodologies are supported?

The solution supports three risk analysis methodologies, each with its own risksheet configuration:
  1. HARA (Hazard Analysis and Risk Assessment) — ISO 14971 Clause 5-8. Uses a 4-level hierarchy (Use Step > Hazard > Event > Harm) with P1xP2 probability model and 5x5 risk acceptability matrix.
  2. DFMEA (Design Failure Mode and Effects Analysis) — Analyzes how design functions can fail. Uses RPN scoring (Severity x Occurrence x Detection) with pre/post-mitigation evaluation.
  3. PFMEA (Process Failure Mode and Effects Analysis) — Analyzes manufacturing process failures. Similar to DFMEA but operates on process steps instead of design functions.
Additionally, a Risk Control Plan risksheet manages all risk controls with their type classification (inherent safety design, protective measure, information for safety).

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How is risk calculated in the HARA?

Risk in the HARA uses a two-factor probability model per ISO 14971:
  • P1 (Hazard Probability): How likely is the hazardous situation? (scale 1-5)
  • P2 (Harm Probability): Given the hazardous situation, how likely is harm? (scale 1-5)
  • Combined Probability P: bucket(P1 x P2), mapped to 5 buckets
  • Risk Level: Determined by a 5x5 matrix of P (combined probability) vs. S (harm severity)
The three possible risk levels are: Acceptable, Investigation Required, and Unacceptable. See Risk Matrix and P1xP2 Probability Model for the full explanation.

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How many work item types are in the solution?

The solution configures 16 work item types across 6 domains:
DomainTypes
RequirementsuserNeed, sysReq, useStep, systemElement
DesigndesReq, function
Riskhazard, harm, riskRecord, failureMode, cause, riskControl
TestingtestCase
ProcessprocessStep, task
Change ManagementchangeRequest, defect
See Work Item Types for detailed field definitions.

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Where do I find the project navigation shortcuts?

The sidebar provides 6 quick-access shortcuts:
  1. Home — Project home dashboard
  2. Risksheets — Risksheet document browser
  3. HARA Report — ISO 14971 HARA Report
  4. Risk Matrix Report — 5x5 risk distribution matrices
  5. RTM Sheet — Whole RTM powersheet (cross-cutting traceability)
  6. DFMEA Summary Report — Executive DFMEA overview
These are configured in .polarion/portal/default_project_favorite_shortcuts.xml.

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How are hazards and harms managed?

Hazards and harms are managed as catalog items stored in dedicated Polarion documents:
CatalogDocumentCountPurpose
Hazards CatalogRisks/Catalogs/HazardsCatalog68 hazardsIEC 60601-aligned hazard taxonomy
Standard HarmsRisks/Catalogs/Standard-Harms25 harmsStandardized harm definitions with severity
These catalogs are pre-populated with industry-standard entries. Risk records link to catalog items via hasHazard and hasHarm link roles rather than duplicating hazard/harm data.

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What is the project space structure?

The solution organizes content across 4 main spaces with 2 sub-spaces:
SpaceContentDashboard
RequirementsUSER-NEEDS, USE-STEPS, SYSTEM-ELEMENTS, SRS-* documentsDocument listing (systemRequirementsSpecification type)
DesignDRS-*, *-Functions documentsDocument listing (designRequirementsSpecification type)
RisksHARA-ANALYSIS, FMEA-, DFMEA-, RiskControlPlanMinimal (uses risksheet browser)
TestingSystemReqsVerification-, DesignReqsVerification-, UserNeedsValidationMinimal
Catalogs (sub-space of Risks)HazardsCatalog, Standard-HarmsMinimal
RiskTemplates (sub-space of Risks)HARATemplate, DFMEATemplate, PFMEATemplate, RiskControlPlanTemplateMinimal

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How do I get help or support?

The solution includes a support booking link on the Project Home Dashboard:
Book a short session to walk through your use case: https://go.nextedy.com/meet
The Documentation space also contains a redirect to the Nextedy powersheet support portal at go.nextedy.com/powersheet-support-portal.