Polarion Medical Device Solution
Combining innovative application lifecycle management technologies with the thorough
knowledge of medical device standards and medical device development experience
- Key ALM functions for regulatory compliance
- Medical device project templates for fast implementation
- Configurable user roles for managers, developers, auditors
- Centralized standards library
- Pre-configured workflows and processes
Polarion´s solution for managing medical device development combines our innovative application lifecycle management technologies with thorough knowledge of medical device standards and the extensive medical device development experience of our partners in the medical devices industry.
The Polarion MedPack plug-in features embedded knowledge of standards like IEC 62304 and FDA 21 CFR Part 11 (Download PDF), 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.
Key Benefits
- Easy development and maintaining of medical device standards using a web-based platform
- Reduced lead time for Audits
- Confirmed development in conjunction with medical device standards (ISO, IEC, FDA)
- 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 an integral 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
"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.
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:
Our Customers
Here are a few examples of our customers in the Medical Devices, Biotechnology and Pharmaceuticals sectors:
Next Steps
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