Software as a Medical Device (SaMD)

The International Medical Device Regulators Forum (IMDRF) defines Software as a Medical Device (SaMD) as follows: “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." It has emerged as a category of medical devices unto itself and has its own regulatory and compliance considerations that must be met.

SaMD is software that has the potential to prevent, diagnose, treat, or mitigate a disease or condition. Examples include diagnostic apps, software for patient monitoring, and treatment planning tools.

As the use of software in medical applications grows, so does the need to ensure these tools operate safely, reliably, and effectively. A smart quality assurance program built on understanding risk within SaMD will address patient safety, data protection and privacy, reliable medical diagnoses and treatments, and trustworthiness in the global market.

Software As a Medical Device Compliance Requirements
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Intertek provides the following services to ensure SaMD compliance:

• Risk Assessment: Evaluate potential risks associated with the software to ensure patient safety.
• Validation & Verification: Confirm that your SaMD meets specified requirements and performs as intended.
• Regulatory Consulting: Navigate the global regulatory landscape with our expert guidance.
• Cybersecurity Testing: Ensure that your SaMD is secure from cyber threats, protecting both patient data and device functionality.
• Interoperability Testing: Confirm that your software works seamlessly with other devices and systems.

Differences between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)

Software in a Medical Device (SiMD): Integral to a medical device, SiMD is the embedded software allowing the device to perform its intended functions. Without SiMD, the medical device could be rendered non-functional. The spotlight of regulation shines primarily on the medical device's safety and effectiveness, treating software as a crucial component. Typical examples include software within MRI machines or pacemakers.

Software as a Medical Device (SaMD): Standing alone in the vast medical domain, SaMD doesn't affiliate with any physical medical device. It holds its ground as a unique medical device, playing pivotal roles in medical diagnosis, monitoring, treatment, and other healthcare functions. As a standalone entity, SaMD faces regulations focusing on its safety, effectiveness, and the fulfillment of its intended medical objectives. Think of SaMD as the medical image analysis software, health-centric mobile apps, or platforms dedicated to remote patient monitoring.

Regulation Scope: SiMD finds its regulatory space as a component of a physical medical device. In contrast, SaMD proudly wears its regulatory badge as an independent medical device.

Operational Independence: SiMD draws its life from the medical device it's nestled in. SaMD, however, stands tall on its own, driven by its core aim to deliver medical knowledge or execute medical operations.

Regulatory Rigor: SaMD often dances to the more specific and rigorous tunes of regulations, given its nature as a standalone device. SiMD, conversely, dances in tandem with the broader regulations guiding the overarching medical device.