Risk Management for Polarion ALM

With RiskPack, you integrate risk management digitally and directly into Polarion in compliance with ISO 14971. It 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 way you have an overview of all dependencies on the development project, save time and prevent contradictions in your documentation. You know at all times how complete your risk management file is. This gives you the security of having thought of everything for your audit.


Conformity to standards

RiskPack helps you to create a risk management file that is compliant with the requirements of ISO 14971.


RiskPack saves you from manually tracking risks, risk control measures, their implementation and verification.


RiskPack gives you a quick overview of how “audit ready” your risk management file is.

Probability of occurrence

Evaluate a sequence of events in terms of probability of occurrence. The assessment of risk acceptance is done automatically based on the known risk policy.

Identify risks

Identify the sequences of events that lead to damage and reference any contributing elements.

Risk governance

Define your risk governance measures and link them directly to the requirements in your development project.

Everything in sight

With the RiskPack, you have a tool with which your risk manager and your development department can systematically and conveniently keep track of everything.

Automatische Rückverfolgung

RiskPack saves you from manually tracking risks, risk control measures, their implementation and verification.


Use prepared checklists to quickly fill your risk analysis with data, for example to identify hazards.

Consulting & contact

Sie haben Fragen zum Thema Risikomanagement?

Further products


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.