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Accelerate medical device innovation and automate proof of compliance

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

  • Automated workflow control includes routing, approval and escalation.
  • Support for unlimited, fully linked variants speeds up development.
  • Synchronize Collaboration In Real Time
  • Polarion Round-trip™ for Microsoft® Word/Excel® smooths external exchange
  • Native RIF/ReqIF exchange with IBM® Rational® DOORS® etc. connects specialists.
  • Automate your Validation and Verification (V&V):

V&V is supported via comprehensive traceability, automated forensic-level accountability, and real-time reporting throughout the lifecycle as well as across projects. Furthermore, it is supported via review and approval of any work item with electronic signature, combined with uninterrupted traceability starting at the design phase.

ISO14971

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

  • Automated workflow control includes routing, approval and escalation.
  • Support for unlimited, fully linked variants speeds up development.
  • Synchronize Collaboration In Real Time
  • Polarion Round-trip™ for Microsoft® Word/Excel® smooths external exchange
  • Native RIF/ReqIF exchange with IBM® Rational® DOORS® etc. connects specialists.
  • Automate your Validation and Verification (V&V):

V&V is supported via comprehensive traceability, automated forensic-level accountability, and real-time reporting throughout the lifecycle as well as across projects. Furthermore, it is supported via review and approval of any work item with electronic signature, combined with uninterrupted traceability starting at the design phase.

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Logiciel intelligent de matériel médical pour un contrôle optimal de la conception

Permettre une conception intelligente grâce à nos solutions innovantes au sein de votre entreprise de matériel médical

Permettre une conception intelligente grâce à nos solutions innovantes au sein de votre entreprise de matériel médical

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