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Two terms, side by side

Pick any two terms to see definitions, context, pitfalls, and sources in parallel.

Software & AI

Software as a Medical Device(SaMD)

In one line

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

Definition

Per IMDRF, Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Why it matters

SaMD spans diagnostic apps, AI triage tools, and CDS systems. IMDRF risk categorization (I–IV) considers the state of the healthcare situation and the significance of the information provided by the SaMD.

Sources

IMDRF SaMD · IMDRF
FDA SaMD Resources · FDA
FDA - AI/ML-Enabled Medical Devices · FDA

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Software & AI

Software in a Medical Device(SiMD)

In one line

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

Definition

Software in a Medical Device (SiMD) refers to software that is embedded within, or required for, the operation of a hardware medical device - such as firmware controlling an infusion pump or imaging system.

Why it matters

Unlike SaMD, SiMD is regulated as part of the parent device. It is still subject to IEC 62304, cybersecurity requirements, and design controls.

Sources

FDA Software Functions · FDA
FDA - AI/ML-Enabled Medical Devices · FDA
IMDRF - Software as a Medical Device · IMDRF

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

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.