last highlighted date: 2024-02-23
Highlights
- IEC 82304-1 is one of many standards that medical device companies should use while developing software as a medical device (SaMD). It covers the requirements for manufacturers building health software products that are used without a dedicated hardware device.
- In fact, IEC 82304 requires the use of IEC 62304 and builds on its requirements in places.
- the definition of health software used in IEC 82304 is much broader than that. The standard defines health software as “software intended to be used specifically for maintaining or improving health of individual persons or the delivery of care.” This could include software not classified as a medical device such as:
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- Prescription management systems
- Laboratory information management systems
- Radiology information systems