08/06/2026
Every industry has its shortcuts.
Medical devices are not one of them.
A software feature may work perfectly on a developer's computer, but that does not replace risk management, verification, validation, and documented evidence.
That's why standards like ISO 14971 exist: to help manufacturers identify hazards, assess risks, implement controls, and demonstrate that products are safe and effective.
Because in MedTech, "it works on my machine" is rarely enough.
