With the Medsoto MedPack as an extension for Polarion, you save configuration effort and have access to an established solution. Of course, the extension can also be used outside of medical technology.
Control
Quick overview of the completeness of your documentation and its conformity with IEC 62304.
Documentation
Easy documentation and linking of the activities required by IEC 62304.
Efficient Product Development
The MedPack accompanies you through the complete software life cycle.
Traceability Reports
A structured data model makes it very easy to create regulatory traceability reports, e.g. between requirements and tests.
Templates
Templates for standard-compliant software and hardware development in medical technology. Simple documentation and linking of the activities required by IEC 62304.
Document Library
With the document library, you manage your templates for your development documentation. It enables e.g. document control according to ISO 13485.
Test Management
A whole range of different MedPack reports usefully extend Polarion’s test management with functions for regression tests, plausibility checks, devices under test, and variant-specific testing.
For more information, contact us at: info@medsoto.de.