Software for ISO 14971 Risk Management

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

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

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

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Aggregate all risks into a single solution

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Compete traceability across the organization.

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

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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.

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