Document according to ISO 14971 specifications – without any extra expense. Compile your risk management files comfortably and audit-proof with the RiskPack.

  • Saves you the manual backtracking/retracing of risks, risk control measures, and implementation and verification.
  • Gives you a quick overview of how “audit ready” your risk management file is.
  • Helps you to create a risk management file that is compliant with the requirements of the FDA and ISO 14971.

With RiskPack for Polarion, you can integrate your risk management for ISO 14971 directly in Polarion ALM.

It supports you in all phases of the risk management process and creates the required regulatory documentation. At the same time you take advantage of all that Polarion offers, because:

  • You can manage all the information in your well known tool. You don‘t have to change your system.
  • You only have to input all your information once, even if it‘s required in several places. This will save you time and potential contradictions in your documentation.
  • You can easily adapt the risk management of your circumstances and requirements. This way you do not have to strain yourself to get efficient risk management.
  • You always know how complete your risk management information is. This will give you security during your audit, knowing you‘ve already thought of everything required.
  • With one simple click you can generate audit-proof documents without having to spend hours manually checking all your references.

How does it work?

Setting the Risk Policy

Define your risk policy directly within Polarion.


Wiki Page “Risk Policy”


Editor for Risk Acceptance

Checklist for Rapid Input

Use prepared checklists to populate your risk analysis quickly, like the identification of hazards.


Checklist for Energy Hazards


Checklist for the Hazard Identification

Identify Potential Harm

Enter all identified potential harm as Polarion artifacts. Through their own attributes they are assigned to categories by severity.


Harm as Polarion Work Items


Specific RiskPack Harm Attributes


Examples of Harm Attributes

Identifying Sequences of Events

Recognize all the sequences of events that can lead to damage, and reference all the factors can can lead to it. Check out the results in a clear, concise table designed to help you.


Work Item: Sequence of Events


Tabular Representation of the Sequence of Events

Risk Assessment

Evaluate sequences of events with respect to their probability of occurrence. The assessment of risk is automatically calculated based on the known risk policy.


Create a sample risk to view the sequence of events.


Work Item “Risk”


Tabular Representation

Risk Control

Create your audit-proof documentation directly from the RiskPack.


Report on Risk Control Measures


Tabular Presentation of Risks and Risk Control Measures


Matrix Representation of Risks Before and After Risk Analysis


Wiki-Template for Risk Management Section

With the RiskPack you have at your disposal a tool that will help you keep track of your risk management and development teams together with your doctors and users. This will help you find and control the risks–for a successful and secure product.

Would you like to test our RiskPack? Please contact us for a trial Version.