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Medical Device Solutions by Polarion®

Accelerate Medical Device Innovation
and Compliance with FDA and IEC Regulations.

Thorough knowledge of industry standards combined with
Application Lifecycle Management (ALM) functionality has proven
to accelerate innovation for our medical customers.

Find out about medical device product development best practices in this joint on-demand webinar: Mitigating and Managing Risk for Medical Device Product Development.
Mitigating and Managing Risk
for Medical Device Product Development


Free Reports on How to Achieve Compliance:

Medical Device Solution Highlights:

1: Fast Compliance with FDA 21 CFR Part 820, Part 11 or IEC 62304

  • Granular, linked work items enable flexibility and focus
  • Bi-directional work item linking delivers full lifecycle traceability
  • Comprehensive, automated work item history furthers compliance
  • PDF and other documentation outputs please the regulators

2: Automated Industry Processes

  • Proven medical processes out-of-the-box can be quickly customized
  • Agile development with bi-directional linking delivers full traceability
  • Automated workflow control includes routing, approval and escalation
  • Support for unlimited, fully linked variants speeds up development

3: Accelerated, Synchronized Collaboration

  • Centralized tool drives real-time collaboration
  • Online “easy-as-Word” authoring speeds up adoption
  • Polarion Round-trip™ for Microsoft® Word/Excel® smoothes exchange
  • Integration with IBM® Rational® DOORS® etc. connects collaborators

4: Intuitive, Cost-Effective Development

  • 100% browser-based access eliminates IT burden
  • Intuitive UI and seamless integration increase productivity
  • Medical workflows drives fast adoption, further reducing TCO*
    *Lowest Total Cost of Ownership (TCO) in the market, per customer feedback

See All ALM Benefits

Medical Device Solutions:

IEC 62304 Compliance »
FDA 21 CFR Part 820 Compliance »
FDA 21 CFR Part 11 Compliance »

Learn More:

View On-Demand Webinars:
Easing IEC 62304 Adoption for Medical Devices
Mitigating and Managing Risk for Medical Device Product Development

Schedule Online Demo: Custom Demonstration by a Medical Expert
Try Now: Try for 30 Days Online or In Your Environment


Customer Examples:

Our Medical Devices Customers

NantHealth finds the way with Polarion

“Sirona Dental Systems uses Polarion to achieve compliance with medical device regulations like FDA or IEC 62304.”

Michael Dalpiaz,
Sirona Dental Systems

Learn More:

Download Customer Success Story PDF

Download Customer Success Story PDF

Download Customer Success Story PDF

“Polarion provides the foundation for submitting for FDA 510K Clearance”

Rafi Heumann,
LifeWatch COO

”Medical Customers report that they can achieve 35% - 50% Cost Savings using Polarion for FDA 21 Part 820 compliance”

Customer Testimonials