Achieve Proof of Compliance, Faster

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

Polarion’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.

Free Reports on How to Achieve Compliance with Polarion:

Medical Solution Highlights

 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

Synchronize Collaboration In Real Time

  • Centralized 100% browser-based tool drives real-time collaboration
  • Online “easy-as-Word” authoring speeds up adoption
  • 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.

Unlock Complexity and Streamline Processes

  • Get started quickly using Polarion work items and workflows and intuitively customize them to reflect unique company processes
  • Enforce workflows in the product development process using the sophisticated rules engine
  • Seamlessly integrate ISO standards and SOP requirements into product requirements
  • Manage QMS documents in Polarion for full traceability and easy proof of compliance
  • Leverage generic Medical Device traceability tables

Automate Proof of Compliance

Extend and Reuse Your Work

  • Integrate Requirements with Verification and Validation (Design V&V) processes
  • Drive requirements into Manufacturing
  • Integrate the design Master Validation Plan
  • Execute flawless design transfer
  • Accelerate external exchanges with Polarion Round-trip and native RIF/ReqIF

Automate Proof of Medical Device Compliance

Create and Manage your company SOPs in Polarion

  • Quickly construct a QMS traceability table
  • Easily integrate SOP requirements with product requirements
  • Benefit from managing all QMS documents in Polarion for multi-directional traceability
  • Effectively plan for and manage internal audits

Help your development group manage complexity

  • Integrate ISO standards with product requirements
  • Establish a Medical Device comprehensive traceability table
  • Easily enforce workflows in the product development process

Extend and Reuse Your Work

  • Integrate Requirements with Verification and Validation (Design V&V) processes
  • Drive requirements into Manufacturing
  • Integrate the design Master Validation Plan
  • Execute flawless design transfer
  • Accelerate external exchanges with Polarion Round-trip and native RIF/ReqIF

Success Stories

Customer Success Story Sirona
“Sirona Dental Systems uses Polarion to achieve compliance with medical device regulations like FDA or IEC 62304.”

Michael Dalpiaz
Sirona Dental Systems

Customer Success Story Lifewatch
"Polarion provides the foundation for submitting for FDA Clearance"

Rafi Heumann,
LifeWatch COO

 

See how you can accelerate innovation while ensuring quality and compliance

Schedule an Online Demo by  a Medical Devices Expert
Give us a call: USA +1 877 572 4005  –   Europe +49 711 489 9969 - 0

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Learn More about Polarion’s Medical Devices Capabilities:

Medical Device Templates:
Polarion Extension Applications:
Learn More About Polarion® ALM