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Polarion ALM MedPack - IEC 62304

 Efficient requirements management, standard-compliant documentation for regulated industries, complete traceability, and test coverage over any number of releases.

Description

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.
Traceability Reports

 

Templates
Templates for standard-compliant software and hardware development in medical technology. Simple documentation and linking of the activities required by IEC 62304.
Templates

 

Document Library
With the document library, you manage your templates for your development documentation. It enables e.g. document control according to ISO 13485.
Document Library

 

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.
Test Management

 

For more information, contact us at: info@medsoto.de.

 

Information

Vendor Medsoto GmbH
Published Version 2018 SR3 HF6 - December 2024
Categories
Price
Supported by Partner This extension is supported by a Siemens PLM Partner.
Requirements Polarion 2017 GA (3.17.0) and newer
Last tested with Polarion 2410 (3.24.10)

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