Embedded systems are dedicated computing units, combining a processor, firmware, and supporting electronics, built into a larger product to control specific functions. In medical devices, an embedded system runs the real-time software that drives sensing, actuation, alarms, and user interfaces inside instruments such as infusion pumps, ventilators, and patient monitors.
What are embedded systems?
An embedded system is a computer designed for one job, or a small set of jobs, rather than general-purpose use. It pairs a microcontroller or microprocessor with memory, sensors, actuators, and firmware: the low-level software written to run directly on that hardware.
In a medical device, the embedded system sits at the center of the product architecture. It reads signals from sensors, applies control logic, drives motors or pumps, manages displays, and raises alarms when readings cross a threshold. When that software has a medical purpose, it falls under the definition of software in a medical device (SiMD) and is regulated accordingly.
Why embedded systems matter in medical device development
In a regulated device, embedded software is often the part that can hurt a patient fastest. A timing fault in a ventilator’s control loop or a miscalculated dose in an infusion pump can cause harm before anyone notices.
The consequences are concrete. Software defects are a leading root cause of device recalls, and embedded firmware bugs have triggered field corrections, injuries, and deaths. A weak software lifecycle also raises audit exposure, since FDA investigators and EU notified bodies review design records and often find gaps in software documentation.
How embedded systems are built under medical device standards
Embedded development in MedTech runs inside a structured lifecycle. The governing standard is IEC 62304, which defines lifecycle processes for medical device software, including software that is an embedded or integral part of a device. It sorts software into three safety classes, A, B, and C, by the harm a failure could cause.
Core activities include:
- Software planning and requirements are traced back to user needs and system inputs.
- Architectural and detailed design, including how the embedded system partitions safety-critical functions.
- Implementation and unit, integration, and system testing with documented results.
- Risk management under ISO 14971, linking each software hazard to a control.
- Configuration management and problem resolution, so every change is tracked.
These activities sit alongside companion standards: ISO 14971 for risk, IEC 60601-1 for electrical safety of the equipment the firmware runs on, and IEC 81001-5-1 for cybersecurity, all inside an ISO 13485 quality system. In the United States, that system now operates under the FDA Quality Management System Regulation (QMSR), effective February 2, 2026, which incorporates ISO 13485:2016 by reference. In the European Union, embedded device software must meet EU MDR 2017/745.
Common challenges and best practices
A frequent mistake is treating embedded code as ordinary software and skipping the traceability that auditors expect. Every requirement should map to a test, and every test result should be on file. Teams that defer documentation pay for it at submission.
Software of unknown provenance (SOUP), such as a real-time operating system or an open-source library, is another weak point. IEC 62304 requires you to identify each SOUP item and assess its risk, yet many teams cannot list what is actually running in their firmware. Cybersecurity is the third gap: an embedded device on a hospital network is an attack surface, and security controls now have to be designed in, not patched later. Good practice means setting the safety class early and building risk and security analysis into the design.
How SJML helps with embedded systems
Syrma Johari MedTech (SJML) designs electromechanical medical devices end-to-end, with embedded systems as a core engineering discipline alongside mechanical, electronics, software, and systems engineering. SJML teams take a program from concept and feasibility through architecture, embedded software development, verification, and design transfer, with risk management to ISO 14971 and usability engineering to IEC 62366-1 built into the workflow. In-house labs support electrical safety and IEC 60601 testing, EMC, and reliability. For software-driven devices, SJML’s QARA group adds IEC 62304 lifecycle support and IEC 81001-5-1 cybersecurity risk assessment.
Talk to SJML’s engineering team →
Frequently asked questions
An embedded system is hardware plus firmware built into a physical device, and its software is often called software in a medical device (SiMD). Software as a medical device (SaMD) is software that performs its medical function without being part of a hardware device, such as an app that analyzes images. Both can fall under IEC 62304, but SaMD ships and updates independently of any single instrument.
IEC 62304 is the primary standard for medical device software lifecycle processes, and it explicitly covers software that is an embedded or integral part of a device. It works alongside ISO 14971 for risk, IEC 60601-1 for electrical safety, and IEC 81001-5-1 for cybersecurity, all inside an ISO 13485 quality system. In the United States, the FDA QMSR now references ISO 13485:2016.
Under IEC 62304, embedded medical software is assigned to one of three safety classes. Class A means no injury or damage to health is possible. Class B means a non-serious injury is possible. Class C means death or serious injury is possible. The class is set after considering risk controls outside the software, and it determines how much development rigor and documentation the standard requires.
SOUP stands for software of unknown provenance: any software item not developed for your device or lacking adequate development records. In embedded systems, common examples include a real-time operating system, a networking stack, or an open-source library. IEC 62304 requires you to identify each SOUP item, document it, and assess the risks it introduces, because you cannot control code you cannot account for.
Related terms
- IEC 62304
- Software in a Medical Device (SiMD)
- Software as a Medical Device (SaMD)
- ISO 14971
- Design Verification
