The healthcare industry is undergoing a major digital transformation, with software playing a central role in improving patient outcomes, enhancing diagnostics, and streamlining medical processes. However, not all medical software is created equal. Two commonly used terms — Software as a Medical Device (SaMD) and traditional device software — represent fundamentally different approaches to how software functions within the healthcare ecosystem.
For organizations planning to develop healthcare technology solutions, understanding this distinction is essential. Whether you’re a startup or an established medical device manufacturer, collaborating with an experienced medical device software development company ensures your software meets the right regulatory, technical, and usability standards.
In this article, we’ll break down the key differences between SaMD and traditional device software, their roles in modern healthcare, and how custom medical device software development can help you build compliant and effective solutions.
What Is SaMD (Software as a Medical Device)?
The International Medical Device Regulators Forum (IMDRF) defines Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
In simple terms, SaMD:
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Operates independently of a physical medical device.
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Can be installed on general-purpose hardware like computers, tablets, or smartphones.
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Is often cloud-based or mobile-app-driven, enabling remote use.
Examples of SaMD include:
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Mobile apps for diagnosing heart conditions using data from wearable devices.
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AI-powered software that analyzes radiology images for early cancer detection.
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Platforms for managing chronic illnesses like diabetes by tracking patient data and providing insights.
SaMD focuses solely on delivering a medical function through software — no dedicated hardware is required.
What Is Traditional Device Software?
In contrast, traditional device software refers to software that is embedded within or directly controls a physical medical device. It cannot function independently and is specifically designed to support the hardware’s operation.
Examples of traditional device software include:
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Embedded software in MRI machines that controls imaging functions.
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Software running inside infusion pumps to regulate fluid delivery.
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Firmware in pacemakers ensuring precise cardiac rhythm control.
This type of software is tightly coupled with the device hardware and typically operates in real-time to ensure safety and accuracy.
Key Differences Between SaMD and Traditional Device Software
While both SaMD and traditional device software fall under the broader category of medical software, they serve different purposes. Here’s how they differ:
1. Dependence on Hardware
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SaMD: Works independently on general-purpose devices like smartphones or laptops.
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Traditional Software: Relies on dedicated hardware and is integral to the functioning of the medical device.
2. Regulatory Framework
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SaMD: Subject to separate regulatory pathways, often with a focus on software-only compliance standards. Regulatory bodies like the FDA and EU MDR have dedicated SaMD guidelines.
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Traditional Software: Reviewed as part of the medical device approval process since it is inseparable from the device.
3. Development Approach
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SaMD: Often uses agile methodologies to deliver frequent updates and enhancements, as it is software-only and can be easily deployed or updated.
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Traditional Software: Follows a more rigid development process, with longer testing and certification cycles due to its hardware dependency and critical nature.
4. Deployment and Updates
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SaMD: Updates can be pushed remotely through the cloud or app stores, making it easy to maintain.
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Traditional Software: Requires physical updates or specialized technical intervention, which can be more time-consuming.
5. Use Cases
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SaMD: Commonly used for diagnostics, disease management, and decision support.
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Traditional Software: Primarily used for direct control of medical devices or real-time patient monitoring.
Partnering with a medical device software development company that understands these distinctions ensures you choose the right approach for your project.
Why the Difference Matters
Understanding whether your software falls under SaMD or traditional device software is critical for several reasons:
1. Regulatory Compliance
SaMD often has different approval requirements than traditional device software. Misclassification could delay product launches or lead to regulatory penalties.
2. Development Strategy
Your development approach will vary based on software type. For instance, custom medical device software development for SaMD often prioritizes scalability and remote deployment, whereas traditional device software development focuses on safety-critical real-time performance.
3. Risk Management
SaMD risks are often associated with data accuracy, cybersecurity, and decision-making. In contrast, traditional device software risks are tied directly to physical device performance, making failure mitigation critical.
4. Cost and Timeline
SaMD projects can often be developed and updated faster due to their independence from hardware cycles. Traditional device software, however, requires longer timelines for testing and certification.
The Role of Custom Medical Device Software Development
Every healthcare solution is unique, which makes custom medical device software development crucial. Off-the-shelf solutions rarely meet the complex needs of medical organizations or comply with the strict regulatory landscape.
By choosing custom development, you gain:
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Tailored functionality: Designed specifically for your use case, whether diagnostic, therapeutic, or operational.
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Regulatory compliance: Development aligned with FDA, EU MDR, and ISO standards.
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Scalability: Especially important for SaMD solutions that need frequent updates or expanded features.
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Integration capabilities: Seamlessly connect with existing healthcare systems, devices, or electronic health records (EHRs).
A seasoned medical device software development company will provide these advantages, ensuring your software meets both technical and compliance requirements.
Best Practices for SaMD and Traditional Device Software Development
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Early Regulatory Consultation: Engage with regulatory experts early to classify your software correctly.
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Adopt IEC 62304 Standards: Follow this international standard for medical device software lifecycle processes.
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Implement Robust Cybersecurity: Especially for SaMD, which often operates on open networks.
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Focus on Usability: Prioritize intuitive design, especially for patient-facing SaMD applications.
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Rigorous Testing: Include both functional and safety testing to ensure reliability under all conditions.
Final Thoughts
Both SaMD and traditional device software are critical to the future of healthcare, but their differences in functionality, deployment, and regulation make it vital to approach their development strategically. Whether you’re building a software-only diagnostic tool or embedded software for a medical device, working with a reliable medical device software development company can streamline the process.