{"head":{"title":"What Is SaMD (Software as a Medical Device)? | OceanLab","description":"SaMD is software that does a medical job on its own, without being part of a hardware device. What counts, what it means for a build, and common mistakes.","canonical":"https://oceanlab.in/glossary/samd"},"crumbs":[{"name":"Home","path":"/"},{"name":"Glossary","path":"/glossary"},{"name":"SaMD","path":"/glossary/samd"}],"slug":"samd","term":"SaMD (software as a medical device)","aka":["software as a medical device"],"category":"Health software","short":"Software meant for one or more medical purposes that does that job on its own, without being part of a hardware medical device.","body":[["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":["If your software is SaMD, medical device rules apply: risk classification, a quality system, clinical evidence and, in many cases, clearance or a ",{"href":"/glossary/conformity-assessment","text":"conformity assessment"}," before sale. That changes budget, timeline and how every release is managed. Wording on the website can move a product into scope."],"example":["A startup's skin app started as a photo diary. When the team added a feature that tells users a mole looks high risk and they should see a doctor, the intended purpose became medical, and the product needed a regulatory plan before that feature could launch."],"inBuild":["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."],"mistakes":[["Adding a diagnostic feature to a wellness app without checking what it does to the regulatory status."],["Marketing copy that makes medical claims the product was not built or cleared for."],["Treating AI model updates as normal releases when they change device performance."]],"related":[{"href":"/glossary/conformity-assessment","label":"Conformity assessment","detail":"The process of showing that a product meets the EU rules that apply to it before it is placed on the market."},{"href":"/glossary/gxp","label":"GxP (good practice regulations)","detail":"The family of good practice rules, such as manufacturing (GMP), clinical (GCP) and laboratory (GLP) practice, that regulated life sciences work must follow."},{"href":"/glossary/audit-trail","label":"Audit trail","detail":"A secure, time-stamped history of who created, changed or deleted a record, kept so the record can be trusted later."},{"href":"/glossary/high-risk-ai-system","label":"High-risk AI system (EU AI Act)","detail":"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."},{"href":"/glossary/llm-evals","label":"LLM evals (evaluations)","detail":"Repeatable tests that score how well a model, prompt or AI feature does a specific task."}],"tools":[{"href":"/tools/mdr-software-classifier","label":"MDR software classifier","detail":"Free tool"},{"href":"/tools/telehealth-app-cost","label":"Telehealth app cost","detail":"Free tool"}],"links":[{"href":"/compliance/eu-mdr","label":"EU MDR guide","detail":"When software is a medical device under EU rules."},{"href":"/software/healthdata","label":"Health data software","detail":"Health records, integrations and data platforms."},{"href":"/software/telehealth","label":"Telehealth software","detail":"Virtual care apps and the rules that apply."}],"sources":[{"title":"FDA, Software as a Medical Device (SaMD)","url":"https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd","checkedAt":"2026-10-25"}],"legal":true,"updatedAt":"2026-10-25"}