SaMD classification under the IMDRF framework, the IEC 62304 software development lifecycle and safety classification, and connected-device cybersecurity basics.
The International Medical Device Regulators Forum defines Software as a Medical Device as software that performs a medical purpose on its own, without being part of a hardware device — a distinction that separates a standalone diagnostic algorithm from the embedded firmware controlling an infusion pump's motor — and this module builds the IMDRF risk categorization framework that scores SaMD by the significance of the information it provides and the seriousness of the healthcare situation it addresses.
It then covers IEC 62304's software safety classification (Class A, B, or C, driven by the severity of harm a software failure could cause) and the structured software development lifecycle the standard requires at each classification level, closing with the cybersecurity fundamentals — attack surface, secure design principles — that Module 19 later develops in full depth for connected and implantable devices specifically.