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Request a Polarion Demo for ISO 13485

Key Aspects of ISO 13485 Medical Devices

  • Functional specification of use

  • User requirement specification

  • Specification for specific configuration

  • Single view of validation status of all systems both operational and performance related

  • Support automated and manual testing

  • Traceability Reports

  • Problem reporting, non-conformances, and CAPAs

  • Faster audits

 

We get it.  Sometimes you are tired of looking at videos and want to see the solution directly and speak with a real person.

Send us your information and we'll schedule a demo within 2 days or find a time that fits your schedule.

No time like the present? Call us to schedule +1.248.247.0055.

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