Polarion ALM MedPack - IEC 62304

 MedPack helps you to fulfill the requirements of the international standard IEC 62304 for medical software life cycle processes with ease. MedPack provides specific Work Item types, link and user roles as well as management, developer and auditor views and traceability analysis options, all directly extended from and backlinked to the standard.


If you are using Polarion ALM within a medical project, you have to fulfill several regulatory requirements. Specific to software life cycle processes is the standard IEC 62304, which is harmonized to the European Medical Device Directive 93/42/EEC. The directive requires to set up and follow software life cycle processes, so de facto you'll have to fulfill IEC 62304.

MedPack for Polarion ALM supports you to do that in many ways by providing:

  • Additional Work Item types with specific attributes that cover all documentation requirements
  • Specific link roles between Work Items to fulfill IEC 62304's strict traceability requirements
  • Traceability analysis support to detect broken traceability before the auditor finds it
  • Specific workflows for each work item type to fulfill verification and evaluation requirements
  • A role concept to fulfill the demand for in dependency between coder and tester or creator and reviewer
  • A lot of wiki pages for different views onto your project


Among the wiki pages you'll find:

  • A topic-based view with interactive links to traceability analyses of
    • Requirements
    • Risk management
    • Product architecture
    • Testing
    • Feedback and problem resolution
    • etc...
  • A developer view that focuses on things to be done
  • A management view that shows the project's progress
  • A notified body view which groups Work Items together in packages the auditor wants to see
    • Software development plan
    • Sofware integration plan
    • Risk management plan


MedPack ships as a project template and also contains a demo project for demonstration.


Here you can find some German spoken videos with following content:


The MedPack 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 2018 SR3 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)

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