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Software for ISO 14971 Risk Management

Why Polarion Software for ISO 14971?

Polarion provides a templated approach to support to the ISO 14971 standard for Risk Management.  

Polarion provides world-class management solution to highlight key risks.  

Polarion provides a templated contruct for ISO 14971 with artifacts to support risks, hazards, hazardous situations, harm, and severity. 

Aggregate all risks into a single solution

Compete traceability across the organization.

Using the above risk analysis, risk estimation, risk evaluation, risk assessment and risk control can be performed as we as identify the residual risk.

Reduced your number of deviations, nonconformances, and recalls.


Never worry about an upcoming audit as the audit status is continually maintained across all systems and teams.


Curated Information

Traceability Basics

Creating a LiveDoc

Easy Linking for Traceability

Import a Word document into a LiveDoc

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