Medical Industry - Polarion ALM

• Compliance
• Traceability
• Risk Management
• Validation and Verification
• Extend and Reuse Your Work

Schedule an Online Demo
by a Medical Devices Expert

  #1 Compliance

• IEC 62304
  
  
• FDA 21 CFR Part 820
  
  
• FDA 21 CFR Part 11
  
  
• ISO 14971:2012 / ISO 14971:2007
  
  

  #2 Full control & history of changes

• Version Control system "SVN"
  
  
• Full History of Changes
  
  
• works & is available "by default"
  
  

  #3 Traceability

• Traceability from User Story to Requiremnts and down to Source Code;
  
  
• Built-in support for ReqIF data exchange, and/or through common document formats such as Word/Excel® or PDF®;
  
  
• Seamless real-time collaboration, contextual visibility improves team effectiveness and intuitive workflow drives rapid adoption;
  
  
• Comprehensive traceability and automated tracking speeds and protects functional safety compliance;
  
  
• Model Driven development with Polarion’s Diagram Editor, plus integration with Sparx Systems Enterprise Architect™ and with MATLAB® Simulink™;
  
  
• Enabling automotive industry project templates facilitate functional safety compliance, process assessment, Agile development practices, and other objectives

  #4 Quality Assurance

• Full Traceability from Request to Implementation: review the impact of planned or implemented change in single click.
  
  
• Baselining & Versioning: Agile means change. In Polarion you can quickly see who changed what, when, and why!
  
  
• Fast Start: Import your existing data from Microsoft® Word or Excel® to create your Product Backlog online, in minutes.
  
  
• Flexible Live Reporting with out-of-the-box sprint and release burn-down charts, kanban boards, total cost/estimate aggregation, velocity calculation, plus an entire portal of other reports and extensions. Everything can be tailored to your data model.
  
  
• Collaboration for Distributed Agile Teams: No out-of-sync emails, all artifacts in one place and always up to date, social media-like project activity streams keep everyone informed.
  
  
• Collaboration in Hybrid Process Scenarios use Polarion's exclusive Round-trip features to share and re-import data with external contributors and Scrum teams.
  
  
• Cross-Project Reporting and Dashboards: view the actual status of all your running projects, search for issues or enhancements across multiple projects. Anything you can find out for 1 project you can find across several.
  
  
• Subversion & Git: Integrates with Subversion and Git out of the box. Link changes from within IDEs like Eclipse for ultimate convenience creating traceability. (Do you know that Polarion is an Eclipse Foundation Member, and we manage the Subversive project?)
  
  

  #5 RISKS Management

• Identify Risk
  
  
• Assess Risk
  
  
• Analyze Risk
  
  
• Control Risk
  
  
• Review Controls
  
  
• Reduce Risk
  
  

• contains items System/Software/Hardware Requirments
  
  
• contains links definition between items
  
  
• contains logic and reports for analysis of risks
  
  
• contains traceability tables for risk overview
  
  
• is re-configurable
  
  
• is documented
  
  

  #6 EMBEDDED SYSTEMS

• Real-time collaboration with intuitive authoring and linking to quickly identify defects, determine impact
  
  
• Comprehensive end-to-end traceability from requirements to code, testing, verification and validation
  
  
• Customizable, pre-built best-practice workflows, cross-discipline reports, and metrics to manage the full product lifecycle
  
  
• Predictive analysis, FMEA risk management and lifecycle project management
  
  
• Use your own existing processes or the ramp fast using expert templates provided for Agile, Waterfall, V-Model, ISO/IEC, FDA, FAA, and hundreds more<
  
  
• Managing requirements, code, test cases, work items of any kind for product variants
  
  
• Track, Trace, or Link any kind of work items one-to-one or one-to-many
  
  

  #7 Standards Support - Compliance in Details