Polarion Software

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
Contact us

 

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
Prof. Christian Johner

"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.

Prof. Christian Johner

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:

ITIG       ITK

Our Customers

Here are a few examples of our customers in the Medical Devices, Biotechnology and Pharmaceuticals sectors:

Boehringer Ingelheim Cellzome

clinIT     GE Healthcare   Getemed

Laetus          Phonak

Fresenius Medical Care          Synthes

 

 

Next Steps

  • Proof of Concept? Call +49 711 489 9969 - 0
  • For special package pricing contact us

 

Follow my track...

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Quality Management

Direct link between Requirement, Test description
and Test definition

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Quality Management

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Risk Management

The scoring in the risk analysis has a direct link
to the Requirements

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Software Development Process

Picture 1: extract of the Wiki page.

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Software Development Process

Picture 2: extract of the implementation of IEC 62304

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Software Development Process

Picture 3: Implemented Wiki-Help. Link between
requirements out of the standards and the implementation.

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Software Development Process

Picture 4: Tree view and the links between the differenty
elements. Traceability primary requirement
out of standard IEC 62304

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Software Development Process

Picture 5: Matrix View

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Software Development Process

Picture 6: In the Wiki page you can mix static
and dynamic parts