SaMD (software as a medical device)
Also called software as a medical device.
Software meant for one or more medical purposes that does that job on its own, without being part of a hardware medical device.
Last updated
What it is.
The definition comes from the International Medical Device Regulators Forum (IMDRF) and is used by the FDA. Software that diagnoses, treats, prevents or monitors a condition can be SaMD, for example an app that analyses images to flag a disease. Software that runs a physical device, such as a pump's firmware, is not SaMD; it is part of that device.
Whether software is SaMD depends on its intended purpose, which is set largely by what you claim it does. Many health apps, such as general wellness or admin tools, are not medical devices at all.
Why it matters
If your software is SaMD, medical device rules apply: risk classification, a quality system, clinical evidence and, in many cases, clearance or a conformity assessment before sale. That changes budget, timeline and how every release is managed. Wording on the website can move a product into scope.
In a product build
We agree the intended purpose and claims with the client before scoping, because that decides the regulatory path. For SaMD we run development under the client's quality system with traceable requirements, risk analysis, verification records and controlled releases.
Common mistakes.
- 01
Adding a diagnostic feature to a wellness app without checking what it does to the regulatory status.
- 02
Marketing copy that makes medical claims the product was not built or cleared for.
- 03
Treating AI model updates as normal releases when they change device performance.
Read the official text.
Primary sources this definition is based on.
- FDA, Software as a Medical Device (SaMD)checked 2026-10-25
Work it out with a tool.
Related terms.
- Conformity assessmentThe process of showing that a product meets the EU rules that apply to it before it is placed on the market.
- GxP (good practice regulations)The family of good practice rules, such as manufacturing (GMP), clinical (GCP) and laboratory (GLP) practice, that regulated life sciences work must follow.
- Audit trailA secure, time-stamped history of who created, changed or deleted a record, kept so the record can be trusted later.
- High-risk AI system (EU AI Act)An AI system the EU AI Act places in its high-risk class, which brings extra duties before and after it is placed on the market.
- LLM evals (evaluations)Repeatable tests that score how well a model, prompt or AI feature does a specific task.
Guides and pages
Browse the full glossary or read answers to common questions.
