How to Achieve IEC 62304 Compliance

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.


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



Software is an integral part of medical device technology. Establishing the safety and effectiveness of such a device’s software requires knowledge of what the software is intended to do and demonstrate that the use of the software fulfills those intentions without causing any unacceptable risks. In this paper, you will learn how medical device manufacturers use Polarion to achieve IEC 62304 and FDA compliance. Here is just a sample of what is covered:


  • Easy-to-use industry proven processes — right out of the box
  • Configurable and secure workflow with automatic revision control
  • Guaranteed Risk and Test Case coverage — with full traceability
  • Browser-based access — anytime, from virtually anywhere
  • Advanced analytics and reporting capabilities
  • And even more…