--- title: "SaMD vs SiMD - side-by-side comparison | MedTech Terms" description: "Software as a Medical Device vs Software in a Medical Device" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "WebPage", "@id": "https://medtechterms.com/compare/samd-vs-simd", "name": "SaMD vs SiMD - MedTech Terms", "description": "Software as a Medical Device vs Software in a Medical Device", "url": "https://medtechterms.com/compare/samd-vs-simd", "about": [ { "@type": "DefinedTerm", "name": "Software as a Medical Device", "url": "https://medtechterms.com/terms/samd" }, { "@type": "DefinedTerm", "name": "Software in a Medical Device", "url": "https://medtechterms.com/terms/simd" } ], "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" } }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Compare", "item": "https://medtechterms.com/compare" }, { "@type": "ListItem", "position": 3, "name": "SaMD vs SiMD", "item": "https://medtechterms.com/compare/samd-vs-simd" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/compare/samd-vs-simd#faq", "mainEntity": [ { "@type": "Question", "name": "Can one product contain both SaMD and SiMD?", "acceptedAnswer": { "@type": "Answer", "text": "Yes. A connected insulin pump has SiMD (pump firmware controlling actuation) and often a companion SaMD (a phone app calculating and recommending bolus doses). Each component follows its own classification path, with the SaMD portion typically requiring its own submission." } }, { "@type": "Question", "name": "Does IMDRF SaMD categorization apply to SiMD?", "acceptedAnswer": { "@type": "Answer", "text": "The IMDRF SaMD risk categorization framework is scoped to SaMD. SiMD risk is captured through ISO 14971 on the whole device and IEC 62304 software safety class on the software item." } }, { "@type": "Question", "name": "Is a mobile app that controls a Bluetooth device SaMD or SiMD?", "acceptedAnswer": { "@type": "Answer", "text": "Usually SiMD if the app is required for safe operation of the hardware device (for example, the sole means of setting therapy parameters). If the app only visualizes data and the device functions safely without it, it is closer to a SaMD companion." } }, { "@type": "Question", "name": "What is the difference between SaMD and SiMD?", "acceptedAnswer": { "@type": "Answer", "text": "SaMD (Software as a Medical Device) performs a medical purpose without being part of a hardware device. SiMD (Software in a Medical Device) is embedded in or required to operate a hardware device, such as pump firmware or imaging system control software." } }, { "@type": "Question", "name": "Is every mobile health app a SaMD?", "acceptedAnswer": { "@type": "Answer", "text": "No. General wellness apps that do not diagnose, treat, cure, mitigate, or prevent disease are typically not SaMD. Once the intended use crosses into medical purposes, the app is regulated as a device in most jurisdictions." } }, { "@type": "Question", "name": "What standards apply to SaMD?", "acceptedAnswer": { "@type": "Answer", "text": "IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 62366-1 (usability), ISO 13485 (QMS), and, for connected products, the FDA cybersecurity guidance and IEC 81001-5-1 all commonly apply." } }, { "@type": "Question", "name": "How does FDA regulate AI-based SaMD?", "acceptedAnswer": { "@type": "Answer", "text": "FDA regulates AI/ML SaMD under the same device framework, with additional guidance on Good Machine Learning Practice and Predetermined Change Control Plans that allow certain model updates without a new submission." } }, { "@type": "Question", "name": "How does SiMD differ from Software as a Medical Device (SaMD)?", "acceptedAnswer": { "@type": "Answer", "text": "SiMD is integral to the functioning of a hardware medical device and is regulated as part of that device. SaMD, in contrast, is software that itself constitutes a medical device and performs a medical function without being part of a hardware medical device." } }, { "@type": "Question", "name": "Is SiMD subject to IEC 62304?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, SiMD is subject to IEC 62304, " } }, { "@type": "Question", "name": "Does SiMD need to comply with cybersecurity regulations?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, SiMD must comply with applicable cybersecurity regulations and guidance, such as FDA's " } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All comparisons](/compare) Compare # SaMD vs SiMD Software as a Medical Device vs Software in a Medical Device SaMD and SiMD describe how medical device software is packaged and regulated. SaMD is standalone software performing a medical purpose. SiMD is software embedded in or required to operate a hardware medical device. The distinction drives which regulatory framework, submission path, and post-market obligations apply. Attribute Software & AI [Software as a Medical Device(SaMD) ](/terms/samd) Software & AI [Software in a Medical Device(SiMD) ](/terms/simd) IMDRF definition Software intended to be used for medical purposes that performs those purposes without being part of a hardware medical device Software that is embedded within, or required for, the operation of a hardware medical device Regulated as A standalone medical device in its own right A component of the parent hardware device (regulated together) Typical form factor Mobile app, cloud service, desktop application Firmware, embedded control software, on-device UI Runs on General-purpose computing platform (phone, PC, cloud) not itself a device Dedicated device hardware or a hardware platform that is itself a device Primary lifecycle standard IEC 62304 (applies to both, but SaMD is where it is most visible) IEC 62304, combined with IEC 60601-1 or IEC 61010 for the hardware Risk framework IMDRF SaMD categorization (I to IV) based on healthcare situation and information significance ISO 14971 applied to the whole device; software safety class per IEC 62304 US FDA submission unit Separate 510(k), De Novo, or PMA on the software itself Part of the hardware device submission EU regulation MDR or IVDR classification rules apply directly (Rule 11 often relevant for SaMD) Assessed as part of the parent device conformity assessment Cybersecurity obligations Section 524B applies if connected; premarket cybersecurity documentation, SBOM, vulnerability management Same 524B obligations flow through the parent cyber device Change control AI/ML PCCP available to pre-authorize model updates without a new submission Software changes governed by device change control; can require new submission if safety or effectiveness affected Examples Diabetic retinopathy screening app; stroke triage cloud service; ejection fraction estimator Infusion pump firmware; MRI console software; ventilator control software Common misuse Treating a wellness app as SaMD when it makes no medical claim Labeling embedded firmware as SaMD to avoid parent-device change control ## When to use which Choose SaMD Classify as SaMD when the software achieves its medical purpose on its own and does not require specific hardware to perform that purpose. General-purpose platforms (phones, PCs, cloud) do not count as the hardware medical device. [Full SaMD page](/terms/samd) Choose SiMD Classify as SiMD when the software is designed to run on, control, or be embedded in a specific hardware medical device, and the device cannot function safely without it. [Full SiMD page](/terms/simd) ## Frequently asked questions Can one product contain both SaMD and SiMD? Yes. A connected insulin pump has [SiMD](/terms/simd) (pump firmware controlling actuation) and often a companion [SaMD](/terms/samd) (a phone app calculating and recommending bolus doses). Each component follows its own classification path, with the SaMD portion typically requiring its own submission. Does IMDRF SaMD categorization apply to SiMD? Is a mobile app that controls a Bluetooth device SaMD or SiMD? What is the difference between SaMD and SiMD? Is every mobile health app a SaMD? What standards apply to SaMD? How does FDA regulate AI-based SaMD? How does SiMD differ from Software as a Medical Device (SaMD)? Is SiMD subject to IEC 62304? Does SiMD need to comply with cybersecurity regulations? Comparison built from the sourced definitions and FAQs on the linked term pages. MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice. MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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