Every two weeks a piece on process applications and medical software. Evidenced, with sources, without marketing promises.
Teams building software with a medical intended purpose know the MDR. For AI-enabled products, a second body of law has applied since 2024: the AI Act. Both operate in parallel, and for many medical devices the AI Act bites precisely where a notified body already assesses. This article shows when an AI medical device counts as high-risk, how the two conformity routes connect, and which deadlines apply.
An AI pilot promises quick wins and is still stuck months later. The cause is rarely the model, but the data beneath it: inconsistent keys, duplicates, missing units. This article describes why data maturity is the actual project — and when AI honestly does not help.
Whether an application is regulated as a medical device is decided by its intended purpose, not by its technology. The same code can be a harmless evaluation tool or software requiring conformity assessment, depending on what the manufacturer says it should do. This article shows what the classification hangs on and how to make it early and deliberately.