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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.  

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

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.  

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

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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