Matrix Requirements and Galen data join forces to become Matrix One
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
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
Maintaining traceability of every requirement from risk to usability to maintenance throughout your software lifecycle.
Download The Guide Now!

If the download does not trigger automatically, click on the download button.
Ready to Transform Your Medical Device Journey?
Download our comprehensive guide on cloud connectivity today and unlock the potential of your innovations.















































































