Software as a medical device
Longevity medicine asks software to do more than store data. The moment a tool informs a clinical judgement it is a medical device, and we treat it as one from the first line of code. The programme is scoped against the frameworks that govern regulated health software, including IEC 62304 for the software lifecycle, ISO 13485 for the quality system, and the Thai FDA's guidance on software as a medical device and artificial intelligence.