How to Achieve IEC 62304 Compliance

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…