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Software for ISO 13485 Medical Devices

Why Polarion Software for ISO 13485?

Polarion provides a templated approach to support to the ISO 13485 standard.  

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Polarion provides world-class management solution for requirements and test management.  

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Limit your risk by providing a single source where compliance standards are stored such as ISO 13485.  With integration to automated test suites, ensure that all systems are validated on every software update.  

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Connect both manual test and automated test into a single view.

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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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Brochures

Curated Information

Traceability Basics

Creating a LiveDoc

Easy Linking for Traceability

Import a Word document into a LiveDoc

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