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Your progress 0 of 9 lessons complete · up next: Software as a Medical Device [Start path](/terms/samd?from=samd-and-ai) 1. 1 [ Software & AI ## Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. Why this term here: The regulatory category for standalone software. Focus on the IMDRF framing and when software is a device at all. ](/terms/samd?from=samd-and-ai)Mark done 2. 2 [ Software & AI ## Software in a Medical Device(SiMD) Software embedded in or required to operate a hardware medical device. Why this term here: Software inside a hardware device. Focus on how SiMD changes your risk analysis and lifecycle scope versus SaMD. ](/terms/simd?from=samd-and-ai)Mark done 3. 3 [ Standards ## IEC 62304 Lifecycle requirements for medical device software. Why this term here: The software lifecycle standard regulators expect. Focus on the process artifacts, not just the class assignment. ](/terms/iec-62304?from=samd-and-ai)Mark done 4. 4 [ Software & AI ## Software Safety Classification IEC 62304 classes A, B, C reflecting potential harm from software failure. Why this term here: Class A/B/C drives how much process rigor applies. Focus on how you justify the class in the risk file. ](/terms/software-safety-class?from=samd-and-ai)Mark done 5. 5 [ Software & AI ## Software of Unknown Provenance(SOUP) Software not developed for medical device use, or lacking adequate development records, incorporated into a device. Why this term here: Third-party software you did not develop. Focus on the evidence you need to keep and the update cadence. ](/terms/soup?from=samd-and-ai)Mark done 6. 6 [ Software & AI ## Clinical Decision Support(CDS) Software providing healthcare professionals with knowledge and patient-specific information. Why this term here: Clinical Decision Support. Focus on the four-factor test that determines whether CDS is a device. ](/terms/cds?from=samd-and-ai)Mark done 7. 7 [ Software & AI ## Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. Why this term here: The mechanism to update a model without a new submission. Focus on what belongs in the plan and what does not. ](/terms/ai-ml-pccp?from=samd-and-ai)Mark done 8. 8 [ Software & AI ## Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. Why this term here: FDA/Health Canada/MHRA principles for AI/ML devices. Focus on the principles most examined in submissions. ](/terms/good-machine-learning-practice?from=samd-and-ai)Mark done 9. 9 [ Software & AI ## Interoperability Ability of devices and systems to exchange and use information. Why this term here: How your software plays with EHRs and other devices. Focus on FDA's interoperability guidance and IEEE 11073. ](/terms/interoperability?from=samd-and-ai)Mark done Finished the path? Test yourself with a quiz tailored to these 9 terms. [Take the SaMD & AI/ML Devices quiz](/quiz?path=samd-and-ai) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. 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