Polarion Software

Contact Us

Live Chat Now

Europe
+49 711 489 9969-0
 USA
+1 877 572 4005
Toll free when dialling in the US

Send us a message

Locations by country

Polarion Software on Twitter Polarion Software on LinkedIn Polarion Software on YouTube Polarion Software Weblog RSS feed

share this page via facebook share this page via LinkedIn share this page via Twitter share this page via Google+ share this page via email More sharing services

 Medical Device Solutions by Polarion

Combining innovative application lifecycle management technologies with the thorough knowledge
of medical device standards and medical device development experience

Challenges
  • Must achieve compliance with diverse standards and regulations
    like FDA 21 CFR Part 820, Part 11 or IEC 62304 quicker
  • Implemented processes, actions and approvals must be proven
    and tracked at a forensic level during the entire lifecycle
  • Audit-related reports must be created faster to meet auditor’s requirements
  • Budget restrictions due to funding being dependent on compliance
    with regulations
  • All upcoming risks must be collected and mitigated properly

Polarion’s medical device solutions combine Polarion ALM, our innovative Application Lifecycle Management product, with thorough knowledge of medical device standards and the extensive medical device development experience of our partners in the medical devices industry. Regulations for software development in the medical device industry ask you to implement a Quality Management System for the entire lifecycle of your products.

Traditionally, to achieve compliance you would labor through mountains of paper documents, tons of disparate digital documents or invest the majority of your budget in costly point solutions. With Polarion ALM you enjoy a requirements-based lifecycle management. A secure audit-trail and accurate traceability for all artifacts throughout the lifecycle are guaranteed. Industry-proven processes out-of-the-box including automated routing, approval and incorporated escalation for overdue tasks reducing cycle times of your tasks come as a bonus.
In minutes you create any reports at any point in time - including forensic level traceability to satisfy any audit. The solutions can be implemented in light speed usually less than 8-10 days.

six key benefits Key Benefits

  1. Achieve compliance with standards and regulations like FDA 21 CFR Part 820, Part 11 or IEC 62304 quicker
  2. Accurate traceability for all artifacts throughout the entire lifecycle
  3. Reduce costs involved to comply with standards and regulations
  4. Industry-proven automated processes delivered out-of-the-box for reuse or customization
  5. Increase end user acceptance and productivity by employing a seamlessly integrated solution
  6. Reduces cycle time of tasks with automated routing, approval and incorporated escalation for overdue tasks

Medical Device Solutions by Polarion:

IEC 62304 Compliance »
Quality Management System for the entire medical product lifecycle
FDA 21 CFR Part 820 Compliance »
Quality Management System for the entire medical product lifecycle
FDA 21 CFR Part 11 Compliance »
Electronic records and signatures Trustworthy, reliable and equivalent to paper records
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 Customers

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

See all customers

 

 

Next Steps