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.

Achieve Proof of Compliance, Faster

Bridge the gap between fast-paced development, complex quality assurance, and proof of compliance.

Siemens PLM Software’s knowledge of industry standards combined with unified Application Lifecycle Management (ALM) capabilities help accelerate innovation for our medical customers, while streamlining quality assurance and automating proof of compliance.

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 customisable templates
  • Automated workflow control includes routing, approval and escalation
  • Support for unlimited, fully linked variants speeds up development

Synchronise Collaboration In Real Time

  • Centralised browser-based tool
  • Online “easy-as-Word” authoring
  • 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 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.