Blog /Healthcare SaMD vs Embedded Medical Device Software: Which One Are You Building? Published byGroovy Web Team Published: Nov 6, 2026 Time to read: 8 min read Add as a preferred source on Google A plain three question test to tell Software as a Medical Device from embedded device software, and what each path means for standards, team and budget. Summarize with AI ChatGPT Claude Perplexity Grok Gemini What Is the Difference Between SaMD and Embedded Medical Device Software? Software as a Medical Device (SaMD) performs a medical purpose on its own. Embedded medical device software runs inside a hardware device and exists to drive it. Which one you are building changes your regulatory path, your team and your budget. Groovy Web builds software for regulated healthcare products from Nadiad, Gujarat. See our medical device software development work, or read how healthcare app compliance works first. This guide gives you a plain test to classify your product, shows what changes after you decide, and lists the mistakes that cost founders months. How Does the FDA Define Software as a Medical Device? The FDA describes SaMD as software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device. The FDA draws this wording from the International Medical Device Regulators Forum, as set out on its Software as a Medical Device page. The same page separates SaMD from software that is integral to a medical device and from software used to make or maintain one. Only the first group, stand-alone software with a medical purpose, is SaMD. What Counts as Embedded Medical Device Software? Embedded software, also called firmware, is the code that runs a hardware device. The FDA's page of examples of Software as a Medical Device names two cases that are not SaMD: software that drives the motors and pumping in an infusion pump, and closed-loop control software in an implantable pacemaker. Short on time? Get the SaMD vs embedded decision test in your inboxOne page with the three question test, the IEC 62304 safety classes and what to confirm before you hire a build team. We email you the PDF. Email me the decision test No spam. Unsubscribe anytime. Industry shorthand for this group is Software in a Medical Device, or SiMD. It is a working label, not a separate legal category, so use it to talk with your team and rely on the FDA wording for filings. Is My Product SaMD or Embedded? A Three Question Test Ask these three questions in order. This is the screen we use in first calls, and it settles most products in minutes. It is a planning aid, not a regulatory ruling. QuestionIf yesIf no 1. Does the software have a medical purpose, such as diagnosing, monitoring or treating?Go to question 2Likely not a device. Confirm with the FDA 2. Does it perform that purpose without being part of a hardware device?SaMDGo to question 3 3. Is its job to drive or control a hardware device?Embedded softwareRe-read the FDA examples with your regulatory lead The FDA states that medical software running on a general purpose computing platform, such as a phone or a consumer camera, is still SaMD. Where the code runs does not decide the class. What it is for does. Which Medical Software Is Usually SaMD? The FDA's own examples range from a smartphone app that displays MRI images for diagnosis to computer-aided detection software that helps find breast cancer. It also lists treatment planning software that feeds a linear accelerator. Typical SaMD projects we are asked about include image analysis tools, clinical decision support, remote monitoring dashboards and digital therapeutics. Software that only encrypts or stores device data has no medical purpose of its own, and the FDA says it is not SaMD. How Do the Build Paths Differ? SaMDEmbedded software Where it runsPhone, browser, cloud or serverMicrocontroller or board inside the device Typical stackMobile, web, cloud, data and AIC or C++, real-time operating system, drivers Release speedUpdates can ship often, with change controlTied to hardware revisions and field updates Hardest partProving clinical performance and data securitySafety, timing and hardware integration Team needsProduct, cloud, data and mobile engineersFirmware and electronics engineers Many products are both. A glucose monitor has firmware in the sensor and an app that reads the data. Plan the two as separate software items with a defined interface, because each has its own risk and testing. What Standards Apply to Either Path? Both paths follow a documented software life cycle. IEC 62304 is the standard for medical device software life cycle processes. It sorts software into three safety classes, and the class sets how much documentation and testing you owe. As explained in Greenlight Guru's guide to IEC 62304 software safety classes, Class A means a failure cannot cause injury, Class B means non-serious injury is possible, and Class C means death or serious injury is possible. Higher classes cost more to build. Your manufacturer quality system matters too. The FDA's Quality Management System Regulation became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference. Your engineering partner's records must fit inside that system. Which Path Costs More and Takes Longer? Neither is always the cheaper one. Cost follows the IEC 62304 safety class and the risk of harm far more than it follows SaMD or embedded. A Class A app can cost less than a Class C firmware module, and a Class C diagnostic app can cost more than both. Embedded work adds hardware cycles and field update planning. SaMD adds clinical evidence, cybersecurity and data handling. Ask any vendor to price documentation and testing as separate lines, so the quote shows where the effort goes. What Mistakes Do Teams Make When Classifying Their Software? Three come up most. Teams treat a wellness app as unregulated when its claims are medical. They merge the firmware and the app into one plan. And they pick a development partner before they know their safety class. FREE · 30 MINUTES · NO OBLIGATION Get a free medical software scoping review Tell us what your product does and who uses it. A senior engineer will help you check the software class and plan the build. Request my free review No sales pitchBuilt for teams comparing voice AI vendorsReply within 1 business day Decide your intended use first, in one written sentence, because claims in your marketing and your labeling shape how the FDA sees the product. Then pick the class, then the partner, in that order. Which Should You Build First? Choose SaMD if: your value is in analysis, decision support or monitoring, and you can use hardware that already exists. You can reach users faster and update more often. Choose embedded software if: your value depends on new hardware that senses, delivers or controls something. Budget for hardware cycles and a longer path to release. Choose both, in stages, if: you need a device and an app. Start with the part that carries the most risk, and define the interface between the two before either team writes code. Bottom line: classify first, then scope. If your software performs a medical purpose on its own, it is SaMD. If its job is to run a device, it is embedded. Confirm the class with a regulatory expert before you sign a build contract. Frequently Asked Questions What is SaMD in simple terms? SaMD is software that does a medical job by itself, such as helping diagnose or monitor a condition, without being built into a hardware device. A mobile app that analyses a scan is a common example. Is firmware in a medical device SaMD? No. The FDA says software that drives or controls a hardware device, like an infusion pump or a pacemaker, is not SaMD. It is still regulated as part of the device and must follow a documented life cycle. Is a mobile health app a medical device? It depends on its intended use. If the app is meant to diagnose, treat or monitor a condition, it can be SaMD. A general wellness or record keeping app may not be. Confirm with the FDA if the claims are borderline. Does IEC 62304 apply to SaMD? Yes. IEC 62304 covers medical device software life cycle processes, and SaMD teams use it to structure planning, design, testing and maintenance. The safety class you assign decides how much evidence you need. Can one product be both SaMD and embedded? Yes. A connected device often has firmware inside and a companion app outside. Treat them as two software items with a documented interface, each with its own risk assessment and tests. Can an India-based team build regulated medical software? Yes, if the team works inside your quality system and keeps the records the standards require. Ask for sample documentation, named engineers and data location terms before you sign. Not Sure Which Path Your Product Takes? Groovy Web builds software for medical device teams and can help you scope the build once your safety class is clear. Tell us what the product does and we will tell you what to confirm before you start. Request a Quote → Related Services Medical Device Software Development Healthcare Software Development Further Reading How Healthcare App Compliance Works What HIPAA Means for AI in Healthcare How Telemedicine Apps Are Built How EMR Integration Works Ship Production-Grade AI with Senior Engineers Our AI-First engineering approach delivers production-ready applications in weeks, not months. Hire an AI-First Engineering Team Was this article helpful? Yes No Thanks for your feedback! We'll use it to improve our content. Written by Groovy Web Team Groovy Web is an AI-First development agency specializing in building production-grade AI applications, multi-agent systems, and enterprise solutions. We've helped 200+ clients ship production-grade software with senior engineers and AI Agent Teams. Hire Us • More Articles
