What’s So Hard About Medical Device Software Compliance?

The IEC 62304 standard for medical device software is causing system engineers worldwide to step back and examine their software development methods with considerable scrutiny. Although at one time, software development and testing was an integral part of overall system design and production, the IEC 62304 standard focuses on software as a separate lifecycle process that requires strong support for risk management and safety assessment. This does not mean, however, that complying with IEC 62304 should necessarily slow down the medical device software development process. By applying best practices guidance and process automation, medical device companies can reap the benefits of getting through regulatory approvals faster, lowering costs, and delivering safer devices.