Efficient requirements management, standard-compliant documentation for regulated industries, complete traceability and test coverage over any number of releases: With the 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.
Features
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/p>
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 the 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.
Testmanagement
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.
Consulting & contact
Would you like to know more about traceability and standards-compliant development?
Further products
Polarion ALM
With Polarion, you digitise and optimise your development processes in all phases of the product life cycle. Define, develop, test and manage complex systems. Transfer documents into structured digital documentation.
RiskPack Pro
Document your risk management completely digitally in Polarion and in compliance with ISO 14971. RiskPack Pro assists you in all phases of the risk management process and creates the documentation required by regulation.
