With RiskPack Pro, you can integrate risk management digitally and directly into Polarion in compliance with ISO 14971. Interactive tables enable flexible views — so you only see what you really need.
RiskPack Pro supports you in all phases of the risk management process and creates the documentation required by regulations. Use one tool for development, documentation and risk management without disruptive media jumps. This gives you an overview of all dependencies on the development project, saves time and prevents inconsistencies in your documentation. You always know how complete your risk management file is. This gives you the security of having thought of everything for your audit.
Features
Conformity to standards
RiskPack Pro offers you the risk management process according to ISO 14971 directly in Polarion
Traceability
RiskPack Pro offers you traceability from hazards to proof of testing of risk control measures
Clarity
RiskPack Pro gives you a quick overview of how “audit ready” your risk management file is.
Risk Policy and Risk Control Matrix
Use the LiveReport Page Risk Policy to define the severity and probability of occurrence rankings. With the help of the LiveReport Page Risk Control Matrix, you can keep track of the risks already identified in relation to the acceptance level you have individually defined. These priorities are automatically embedded in the two LiveDocs Risk Management Plan and Report.
Interactive charts
Edit and evaluate risks in interactive charts directly in Polarion. Use flexible views and manage and edit exactly the information you need at that moment.
Full traceability & seamless integration
Check the traceability of components or hazards up to the test verification of the risk control measure. Add and change data directly in the editable table. The corresponding links are created automatically.
Use data from existing Polarion projects: Link your risk management directly to your development or usability engineering process. Check and edit data across projects in one place.
Lean data model
With three interactive tables, you can keep an eye on the entire risk management process in accordance with 14971 — clearer and more convenient than ever before.
Risk Management Tasks
Use the prepared plans and tasks to track your process progress and maintain an overview. On the homepage you will find a process cockpit to help you navigate the project and complete tasks.
Plan and Report
Use the prepared LiveDocs Risk Management Plan and Report to depict the essential contents of the risk management process. Together with an excerpt from the interactive tables, you can complete your ISO 14971-compliant documentation.
Consulting & contact
Do you have questions about risk management?
Further products
MedPack
Our industry-specific extension MedPack for Polarion: Efficient requirements management, standard-compliant documentation, complete traceability and test coverage over any number of releases.
Polarion ALM
With Polarion, you digitise and optimise your development processes in all phases of the product life cycle. Define, develop, test and manage complex systems. Transfer documents into structured digital documentation.
