Medical Device Software and Health Software

Building medical device software? It's not just about IEC 62304.

To implement medical device software, manufacturers must deal with a layered standard environment. It’s not one-size-fits-all. Start with the foundational standards:

• ISO 13485 for quality management

• ISO 14971 for risk management

• IEC 62304 for software lifecycle

• IEC 62366 for usability

These set the base, but depending on your software’s setup, complexity, and where it runs

More standards come into play:

• IEC 60601-x for hardware integration

• ISO 15223-1 for symbols

• IEC 82304-1 for standalone health software

• And many many others depending on your case

These standards aren’t isolated. They connect. Together, they shape a compliant, traceable, and safe software development process. What matters?

Maintaining traceability of every requirement from risk to usability to maintenance throughout your software lifecycle.

And that’s where teams hit a wall. Excel spreadsheets don’t cut it. Generic tools miss key traceability steps. MatrixReq is purpose-built for this. An ALM platform aligned with the IEC 62304 standard and its normative environment.

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