Achieve Fast Compliance with IEC 62304

IEC 62304 Solution Benefits:

  • Prove the implementation of processes, actions and approvals
  • Track all actions at a forensic level throughout the entire lifecycle
  • Discover and mitigate all upcoming risks in a systematic way
  • Report all relevant information in auditor-ready-style

Traditionally, to achieve IEC 62304 compliance, you would labor through mountains of paper documents and disparate digital information, or invest in costly Document Management Systems. With Polarion, you can create any reports and export them at any point in time, including forensic level traceability, to satisfy any audit.

How to Achieve IEC 62304 Compliance

In this paper, you will learn how medical device manufacturers use Polarion to achieve IEC 62304 and FDA compliance.

IEC 62304 Solution Highlights:

  • Automation of Validation and Verification (V&V)
  • Accurate traceability for all artifacts throughout the entire lifecycle
  • Electronic signatures for changes and approvals
  • Out-of-the-box templates and processes can be easily customized
  • Automated routing, approval and incorporated escalation for overdue tasks
  • Secure, time-stamped audit trails (exceeding IEC requirements)
  • Increased management oversight through advanced analytics and reports

Michael Dalpiaz | Sirona Dental Systems

Customer Success Story Sirona

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



Rafi Heumann | LifeWatch COO

Customer Success Story Lifewatch

"Polarion provides the foundation for submitting for FDA Clearance"

Learn More About Polarion for Medical Devices

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