Polarion for Medical Devices

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

• Leverage Polarion’s compliant electronic signature functionality for FDA 21 CFR Part 11
• Fully integrate company product design controls
• Easily set up automated traceability across design, manufacturing, and testing
• Plan user management and improve release predictability

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

• Leverage Polarion’s compliant electronic signature functionality for FDA 21 CFR Part 11
• Full integration of company product design controls
• Very specific requirements traceability including integration with design, manufacturing, and testing traceability
• Predictable user management and integrated workflows

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 >