27/10/2026
How do you prove Software as a Medical Device (SaMD) does what it claims?
That’s where validation comes in.
SaMD needs evidence that it performs as intended, is safe to use and delivers reliable results in its intended clinical setting.
That can include technical testing, usability studies and clinical evaluation — all linked back to the device’s intended purpose.
In short: it’s not enough for the software to work. You need evidence that it works as intended.