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Polarion for Medical Devices


Accelerate Medical Device Innovation and Automate Proof of Compliance

Software has become the key differentiator for manufacturers of medical devices. There are countless opportunities for software innovation, but are counterbalanced by stringent quality requirements, risks of product failure, and growing regulatory complexities.

Automate Risk Management and Compliance

  • Workflow control of individual work items enables streamlined, interdependent processes

  • Linking of work items delivers full traceability throughout the lifecycle and across projects

  • Comprehensive, automated history of all artifacts facilitates proof of compliance - Integrate risk management processes leveraging the ISO 14971 Template

Quick-Start with Automated Industry Processes

  • Proven medical processes including the above customizable templates help get your started

  • Automated workflow control includes routing, approval and escalation

  • Support for unlimited, fully linked variants speeds up development

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