How Open COM Standards and Edge AI Support Compliance with Evolving Medical Regulations

Highly advanced electronic systems are now used across many areas of medical technology. Examples include digital X-ray systems for diagnostic imaging, interactive HMIs for patient monitoring, and automated laboratory systems for clinical analysis. While these technologies significantly improve care quality, they also confront manufacturers with increasingly stringent regulatory requirements.

International standards such as IEC 60601, IEC 62304, and IEC 14971 define strict requirements for patient safety, the development and maintenance of electronic medical devices, and systematic risk management. At the same time, the EU 2017/745 Medical Device Regulation (MDR), as well as US-equivalent frameworks enforced by the Food and Drug Administration (FDA), places growing emphasis on cybersecurity and data protection. The common objective of these regulations is to ensure that system failures, software defects, or cyberattacks never compromise patient safety.

Based on SECO’s broad project experience, one of the greatest challenges for manufacturers is maintaining compliance throughout the entire product lifecycle. Even the replacement of individual components can trigger complex and costly recertification processes. As a result, system architecture becomes a key factor in ensuring long-term regulatory robustness.

The modular advantage for modern medical design

Traditionally, many medical device manufacturers have relied on custom-built systems with monolithic architectures. In such designs, processing units, interfaces, and application-specific functions are tightly coupled and often integrated on a single PCB or computing module. This approach introduces a significant risk: the obsolescence of a single component can necessitate replacing and recertifying the entire system, leading to high follow-up costs and complicating long-term operation and maintenance.

From SECO’s experience, modular design approaches offer substantial advantages over monolithic systems. By decoupling key components, such as the computing module, from application-specific hardware, individual elements can be replaced in a targeted manner without altering the fundamental system architecture. In many medical devices, circuits that directly interact with patients are intentionally placed on separate printed circuit boards (PCBs) or modules for safety and isolation reasons. This physical separation allows sensitive sensing, actuation, and interface circuits to be designed and validated independently from the central computing logic.

In such architectures, computer-on-modules (COMs) provide system intelligence, while carrier boards or dedicated I/O and isolation boards implement application- and patient-specific functions. Also known as system-on-modules (SOMs), COMs can be replaced easily with newer generations, without affecting patient-adjacent circuits or their safety-relevant characteristics. This architectural stability significantly simplifies regulatory assessments, particularly regarding the MDR and the question of whether a change constitutes a “significant change” under Article 120 that would require recertification.

Easier lifecycle management through COM-based design

SECO offers a broad portfolio of open COM standards, which help support compliance with regulatory requirements for medical devices. By separating system intelligence from physical interfaces, they enable targeted hardware updates without impacting the underlying safety architecture. In many cases, such updates on these separate circuit card assemblies can be classified as non-significant changes, reducing the need for extensive redesigns along with associated verification and documentation, and helping to satisfy regulatory authorities, while saving time and cost.

Open COM standards provide additional benefits: Modules based on the same standard use a well-defined, vendor-independent interface to the carrier board, enabling true plug-and-play replacement even when suppliers change. Furthermore, the long lifecycle availability of COMs reduces electronic waste and supports corporate sustainability goals. To address diverse medical requirements, three COM form factors are particularly relevant:

Table 1: Comparison of SMARC, COM Express, and COM-HPC for Medical Applications

The decisive factor is not necessarily choosing the “best” standard but selecting a platform early on that aligns with the device’s functional and regulatory roadmap, a decision that, in many projects, is made too late. SECO experts support project engineers in selecting the most appropriate COM for each application, with one of today’s more popular options being SGeT’s SMARC standard.

How Intel Atom processors increase patient safety and data privacy

While COM standards largely define system architecture and lifecycle management, the choice of processor directly affects how patient safety and cybersecurity requirements are implemented.

Modern medical devices require embedded platforms that support these aspects at the hardware level. In addition to providing sufficient computing performance, they must enable deterministic behavior, safe operation, and data protection. One example is the Intel Atom x7000RE processor series used on SMARC modules such as the SECO SOM-SMARC-ASL.

See Figure 1

Figure 1: The SECO SOM-SMARC-ASL is based on energy-efficient Intel Atom x7000RE processor series with a wide range of graphics, I/O and high-speed interfaces. (Figure: SECO)

Intel Atom x7000RE processors combine energy-efficient performance with deterministic operation enabled by Time-Sensitive Networking (TSN) and Intel Time Coordinated Computing (TCC). This makes them well suited for precise measurements, time-critical control tasks, and reliable dosing processes. Integrated Vector Neural Network Instructions (VNNI) enable AI workloads to run directly at the edge, ensuring that functions such as intelligent patient monitoring or image pre-processing remain available even in the absence of continuous network connectivity. These capabilities are becoming increasingly popular in devices like portable ultrasound machines, ECG monitors, and surgical equipment with voice AI capabilities, where they improve latency and patient privacy (HIPAA) concerns associated with transmitting data to the cloud.

Additional mechanisms, such as In-Band Error Correction Code (IBECC), reduce the risk of memory-related failures, while secure boot and a trusted platform module (TPM) establish a hardware root of trust. Together, these features support risk control in accordance with IEC 14971 and help meet further FDA and EU cybersecurity requirements.

The Intel Atom x7000RE series also supports multiple independent 4K displays without the need for an external GPU. This is particularly relevant for medical imaging, user interfaces, and multi-monitor workstations requiring high resolution and consistent visual output. Eliminating additional graphics components simplifies thermal design and reduces potential failure points, facilitating safety assessments under IEC 60601-1.  

Combined with SECO’s Clea OS, this results in a powerful, future-proof platform for secure and compliant medical devices. Clea OS extends the modular philosophy into software by providing a hardware‑agnostic, Yocto Linux-based distribution delivered under a long‑term‑support model with quarterly updates and common vulnerability and exposure (CVE) patching. It also embeds automated software bill‑of‑materials (SBOM) generation into its security framework, producing a detailed inventory of every software component and version used on a device.  

By building the SBOM directly into the operating system framework, Clea OS removes the manual burden of compiling component lists and ensures that every update or third‑party library is traced and documented. This capability aligns with emerging laws such as the EU Cyber Resilience Act and the FDA’s cybersecurity guidance, which treat SBOMs as a foundation for risk management.

Conclusion

SECO’s COM-based designs enable medical device manufacturers to extend product lifecycles and implement necessary hardware updates through delta testing rather than full reassessment, significantly reducing the time and cost of recertification.  

At the same time, modern edge-AI capabilities provided by processors such as the Intel Atom x7000RE series enhance patient safety and data protection, lowering regulatory barriers. Ultimately, long-term success depends not only on selecting capable hardware, but on the ability to evolve existing platforms without fundamental redesign, through architectures that support controlled change and long-term regulatory viability.

Further information on SECO’s modular COM-based platforms and Intel Atom–based solutions is available on the dedicated product pages.

If these architectural considerations are relevant to your current or upcoming projects, you can contact us to start a technical discussion and explore how different modular approaches may support your specific regulatory and application requirements.