Polarion ALM RiskPack - ISO 14971

 The RiskPack for Polarion supports ISO 14971 compliant risk management for medical devices within Polarion.


With RiskPack for Polarion you integrate your risk management according to ISO 14971 directly into Polarion. It supports you in all phases of the risk management process and creates all necessary documentation. Along with this, you can benefit from all of Polarion's advantages, meaning that ...

  • You manage all your information within your familiar tool, so you don't waste time with learning to deal with yet another one.
  • You need to enter all information only once, even if you need it at several locations. That saves time and reduces contradictions within your documentation.
  • You can adapt your risk management precisely to your situation and needs. You only do the amount of work necessary for an efficient risk management.
  • You know at one glance how complete your risk management documentation is. That prevents you from overlooking something important.
  • You can create audit proof documentation with a single click, without having to check references manually for hours.


The RiskPack for Polarion is a commercial extension, trial versions can be requested via e-mail, please write to or use the contact form on our homepage at (German).



Vendor Medsoto GmbH
Published Version 2016 SR1 HF2 - December 2022
Supported by Partner This extension is supported by a Siemens PLM Partner.
Requirements Tested for Polarion 2017 GA (3.17.0) to 22 R2 (3.22.2)
Last tested with Polarion 22 R2 (3.22.2)