IEC 62304

IEC 62304 classes A, B, C reflecting potential harm from software failure.

Software intended for medical purposes that performs without being part of a hardware device.

Software not developed for medical device use, or lacking adequate development records, incorporated into a device.

International standard for the application of risk management to medical devices.

Software embedded in or required to operate a hardware medical device.

Software providing healthcare professionals with knowledge and patient-specific information.

FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.

Guiding principles for the development of AI/ML-enabled medical devices.

International standard defining secure-product-lifecycle activities for health software, including medical devices.

EMC requirements for medical electrical equipment.

Application of usability engineering to medical devices.

General requirements for basic safety and essential performance of medical electrical equipment.

The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.

A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.

A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device.

A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.