MedPack works in conjunction with Polarion ALM (Application Lifecycle Management) to reach a complete solution to developing medical software quickly and in compliance with IEC 62304.

With our MedPack, you will compile a fast and reliable management tool for your development processes, document all of the IEC 62304 requirements, and establish the necessary traceability.

MedPack …

  • relieves you from your battle against paper: Spare yourself error-prone, manual documentation and linking of the documents and activities for the IEC 62304. The MedPack manages, links, and visualizes the required information for you.
  • gives you back time you can use for further development: The need to study intensively and interpret the rules for yourself are rendered largely redundant. The MedPack supports all the life cycle processes, including risk management. Bug-tracking, documentation of requirements and testing, release, and much more are integrated here into just one tool.
  • provides security during your audits: You have an overview of the completion of your documentation and its conformity with the IEC 62304 at a glance. This treatment of your data will also convince your auditor. The Medpack also supports you during the review and approval of your documentation. Thanks to an integrated life cycle for all information, you can be sure not to overlook anything and more is integrated within just a single tool.
  • is easy to use: Auditors, project managers and developers will find the system easy to navigate, since the same data for each of them are specifically shown. This way, everyone sees only what is necessary for him or her and in a familiar language. Thanks to the browser-based clients, you can work even across locations.

With MedPack you can document all activities required by the IEC 62304, and thereby produce the required “Traceability” to conform to the standards.

Do you have any further questions regarding our products or Services? Please feel free to contact us!