"Polarion provides the complete Infrastructure. All important components like Configuration Management, Traceability, Process support, Documentation and Checklists are not only available they are all pre-configured and integrated.
Polarion MedPacks (Switch to German 
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Polarion MedPacks combine innovative application lifecycle management technologies of Polarion Software with the thorough knowledge of medical device standards and medical device development experience of our partners in the medical device industry.
MedPacks feature embedded knowledge of ISO and IEC standards, combined with pre-fabricated project structures and workflows (all easily customizable and reusable). All aspects of the standards are supported.
Development teams save time implementing to standard with built-in Audits reviewed by our expert partners to ensure that all aspects of the standards are covered. The full-featured Wiki, with significant information already provided, ensures that non-technical stakeholders can easily access and work with MedPack solutions.
Our Partners
These partner companies have contributed their knowledge and expertise in the field of medical device development and standards. They have "done the legwork", so you don´t have to.
Institute for Informationtechnology for Health Care
INNOMEDIC Gesellschaft für
innovative Medizintechnik und Informatik mbH
ITK Engineering AG
Key Benefits
- Easy development and maintaining of medical standards using a web-based platform
- Reduced lead time for Audits
- Confirmed development in conjunction with the medical standards (ISO, IEC)
- Proactive and traceable Quality Management with full traceability throughout the entire development process
- Reuse of standards
- Functional and requirements specifications always at your fingertips
- Documented product development
- Risk management is part of the Time and Project planning
Major Coverage Areas
- Risk-oriented Requirements Management
- Test Case Management
- Bug Tracking and Change Management
- Project control and management
- Integrated Risk Management and Risk analysis
- Integrated Wiki
- Report Generator
- Document Management
- One server, one user interface – easy set-up, easy to use on Windows or Linux.
Key Features
- Medical device project templates for fast implementation
- Pre-configured development workflows and proven processes
- Centralized, up-to-date standards library
Next Steps
- Detailed information on Polarion ALM MedPack
- Register for free Online Demo
- Get access to Polarion Test Drive Servers
- Proof of Concept? Call +49 711 489 9969 - 0
- Contact Polarion info@polarion.com
Screenshots
Quality Management
Direct link between Requirement, Test description and Testdefinition
Risk Management
The scoring in the risk analysis has a direct link to the Requirements
Software Development Process
Picture 1: extract of the Wiki page: 
Picture 2: extract of the implementation of 62304
Picture 3: Implemented Wiki-Help. Link between requirements out of the standards and the implementation.
Picture 4: Tree view and the links between the different elements. Traceability primary requirement out of standard 62304
Picture 5: Matrix View
Picture 6: In the Wiki page you can mix static and dynamic parts
