What is IEC 62304 and Why Does It Matter?

If you work with medical device software, you’ve likely come across IEC 62304—the international standard that defines the software life cycle processes for medical devices. It lays out requirements for development, maintenance, risk management, and software safety classification, ensuring that medical software is safe, reliable, and compliant with regulations.

Now, with Edition 2 on the horizon, IEC 62304 is evolving, bringing significant updates to expand its reach and modernize key aspects of software safety.

What’s Changing in IEC 62304 Edition 2?

🚀 A Broader Scope
IEC 62304 is no longer just about medical device software—it’s expanding to cover health software as a whole, leading to wider implications across the industry.

Other key changes include:
🔹 A revamped software safety classification, moving from three levels to just two.
🔹 Modernization efforts, including AI finally getting a seat at the table.

Want to Learn More?
Join us this Thursday (March 27) at 12:30 as we discuss these updates and what they mean for the future of health software or contact us directly to discuss the topic! 🚀

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