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1Clear out junk files and repair common Windows errors2Scan for outdated or missing drivers - takes under a minute3Repair Windows errors before they cause bigger problemsAn electronic quality management system (eQMS) is software a medical-device manufacturer uses to manage or automate quality-system activities. It is not the quality management system itself, and purchasing one does not make a manufacturer compliant. SaMD—software as a medical device—is a different category: software that is itself intended to serve a medical purpose.
What an eQMS does—and what it does not do
A quality management system (QMS) is the manufacturer’s organized set of processes and responsibilities for managing quality. An eQMS is a software tool used to support those activities. Depending on the product and how a company configures it, an eQMS may support controlled records and other quality workflows, such as complaint handling or corrective actions.
The distinction matters: software can help a manufacturer operate and document its QMS, but the manufacturer remains responsible for meeting requirements that apply to its devices and operations. A vendor’s product, documentation, or assurance materials do not transfer that responsibility or amount to a compliance certificate.
How eQMS, SaMD, and device-integral software differ
These terms describe different roles software can play. FDA’s description of SaMD uses the IMDRF definition: “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
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| Software role | What it means | Relevant distinction |
|---|---|---|
| eQMS or other QMS software | Software used to support or automate a manufacturer’s quality-system activities. | It is a tool used within the QMS, not a medical device merely because a medical-device manufacturer uses it. |
| SaMD | Software that is itself a medical device and performs a medical purpose without being part of hardware. | Its intended medical purpose is central to whether it falls within the device concept. |
| Software integral to a medical device | Software that is part of, or embedded in, a medical device. | It is not the same category as standalone SaMD or software used to run a manufacturer’s QMS. |
FDA’s SaMD explanation attributes the quoted definition to the International Medical Device Regulators Forum (IMDRF). Whether a particular app or software product is regulated as a device depends on its intended use and applicable device requirements; the label “health app” or the fact that a company sells software does not, by itself, settle the question.
What the US QMSR means for manufacturers
FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026. It amended 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. FDA says the regulation applies to manufacturers of finished devices intended for commercial distribution; accessory manufacturers may also be subject to it. Applicability depends on the product and manufacturer’s circumstances, so this is not a rule that automatically covers every health app or software company.
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QMSR inspections use FDA’s updated inspection process, which replaced QSIT on the effective date. FDA also says inspectors may review QMS records created before that date, and that management-review, quality-audit, and supplier-audit reports may be inspected under QMSR.
FDA states that if ISO 13485 conflicts with the Federal Food, Drug, and Cosmetic Act or its implementing regulations, the law or regulation controls. The QMSR is a US regulatory baseline; this description does not establish requirements in other jurisdictions or determine the status of a particular product.
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How FDA expects manufacturers to approach software assurance
FDA’s February 2026 final guidance, Computer Software Assurance for Production and Quality Management System Software, recommends a risk-based approach to establishing confidence in software used in production or a QMS. It describes considering where additional rigor is appropriate and gives possible methods and testing activities. It supersedes FDA’s September 24, 2025 guidance on the same subject.
The guidance is not a blanket instruction to use one validation method for every system. The manufacturer should determine and document an approach appropriate to the software’s intended use and the risks associated with its use in the process. A vendor’s evidence may inform that assessment, but the manufacturer must decide whether it is sufficient for its own configuration, workflows, and QMS.
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Practical questions for an eQMS assessment
- Which quality workflows and records must the system support in your actual QMS?
- What assurance evidence is available, and how will you assess its relevance to your intended use and configuration?
- How are system changes controlled, assessed, and documented after implementation?
- How will access, data handling, implementation, and ongoing support work in your operating environment?
- How does the system fit alongside the controls and lifecycle activities for any SaMD you develop?
These are evaluation considerations, not a vendor ranking or a guarantee that a particular feature set meets regulatory requirements. The appropriate evidence and controls depend on the manufacturer’s use of the system.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Where ISO/TR 80002-2 and IEC 62304 fit
ISO/TR 80002-2:2017 addresses software used in device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, other QMS automation, production and service provision, and monitoring and measurement. It excludes software that is itself a medical device or a component, part, or accessory of one. ISO lists the 84-page report as published and offers paper and PDF formats.
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IEC 62304:2006+A1:2015 addresses lifecycle requirements for development and maintenance of software that is itself a medical device or is embedded in or integral to one. FDA’s recognized-standards database entry says the standard does not cover validation and final release of the medical device. It is therefore a software lifecycle standard, not a replacement for the manufacturer’s full QMS.
The standards address different software contexts. A manufacturer may need to consider QMS software assurance and its device-software lifecycle processes separately; choosing a standard or buying a tool does not, on its own, answer every applicable regulatory obligation.
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