Polarion Medical Device Design Control

Real World 101 Business Best Practices

Achieve Proof of Compliance, Faster

Bridge the gap between fast-paced development, complex quality assurance, and cumbersome 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 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

Polarion ALM gives organizations one unified solution that delivers project transparency through real-time aggregated management information. Everyone is aligned around what is being built and why to drive advancement while protecting integrity and compliance. This helps teams respond faster and with better quality to new business opportunities and customer demand.

Immediate Benefits and Value

  • Unlock synergies across all collaborators with 100% browser-based access to a single data source
  • Increase productivity with intuitive and role-based user interface
  • Achieve better quality and regulatory compliance through end-to-end traceability and automated audit trails
  • Adopt modern agile techniques at once or incrementally with out of the box project templates that can be adjusted to your needs
  • Optimize planning, prioritization and release predictability via flexible planning and real-time reporting

See All ALM Benefits >


Michael Dalpiaz | Sirona Dental Systems

Customer Success Story Sirona

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



Rafi Heumann | LifeWatch COO

Customer Success Story Lifewatch

"Polarion provides the foundation for submitting for FDA Clearance"

Learn More About Polarion for Medical Devices

Software Support & Maintenance Packages

Buy the support you need for your on-premise or hosted Polarion solution.

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Contact Support

Customer Service Portal Access
Customer's Preferred Choice! Easiest way to ask & track progress over support cases.

Not a customer yet?
Contact us for general inquiries at:
USA      +1 877 572 4005
 Europe  +49 711 489 9969 - 0
 Live Chat

Training & Consulting

Our expert trainers can help you improve your development process with best practices, in-depth know-how, and tips-and-tricks to get the most out of your investment.

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Effective Polarion® Licensing

Combine 5 Product Configurations - Optimize Capabilities - Lower Your Total Cost of Ownership.

Select the number and type of configurations you need to unify and empower different users on your team.

See more details about licensing >


See how you can accelerate innovation while ensuring quality and compliance

One of our Polarion experts will give you a one-on-one guided tour of the pioneering application lifecycle management software that is currently used by more than 10,000 firms worldwide to create better complex software, faster.

Give us a call: USA +1 877 572 4005 – Europe +49 711 489 9969 - 0

Try it now >