Medical Device Software

Software plays a pivotal role in modern healthcare systems, transforming the landscape of medical devices and patient care. This article will explain the definitions of SaMD and SiMD and their relevant regulations.

In the evolving landscape of medical technology, the distinction between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) plays a crucial role in both regulatory compliance and validation processes. These categories define how software is integrated into medical devices and how it impacts their validation and regulatory pathways.

Software as a Medical Device (SaMD) refers to software intended to be used for medical purposes without being part of a hardware medical device. These could include mobile apps, clinical decision support software, or software for monitoring patients remotely. SaMD operates independently of any specific hardware and can function on general-purpose computing platforms.

Software in a Medical Device (SiMD) refers to software that is an integral part of a medical device’s functionality. Unlike SaMD, SiMD operates within the confines of a specific medical device and is designed to contribute directly to its operation, control, or monitoring. Examples include embedded software in imaging devices or diagnostic equipment.

SaMD and SiMD follow the following regulations/standards:

·?????? FDA pre-market submission for device software functions – relates to both SaMD and SiMS. SaMD is a medical device (even if it is on its own) and SiMD is a component in a medical device.

·?????? IEC 62304 – is an international standard that specifies requirements for the software life cycle processes of medical device software. It outlines the framework for developing, maintaining, and managing medical device software throughout its entire lifecycle. Compliance with IEC 62304 is crucial for manufacturers to demonstrate that their medical device software has been developed and managed according to recognized best practices in the industry. Note that this regulation is applicable to all types of medical device software.

·?????? IEC 82304-1 – This standard defines requirements at system level for health software systems. It deals with any kind of software, which directly or indirectly has an effect on health and deals only with standalone software, i.e., SaMD.

·?????? IEC 60601-1 – defines requirements at system level for Programmable Electric Medical Systems (PEMS). ?SiMD has additional requirements concerning hardware and software integration to ensure overall medical device safety and performance.

·?????? IEC 62366 - this standard pertains the usability of medical devices, specifically focusing on the design process to ensure the safety and effectiveness of these devices. This standard is relevant both to SaMD and SiMD.

·?????? ISO 14971 – this risk management standard relates both to SaMD and SiMD. While innovators must assess risks related to SaMD for its intended medical purpose, SiMD poses higher risks due to its integration with hardware. Failure to ensure seamless integration may compromise the overall safety and performance of the medical device.

·?????? ISO 27799 - applies to health information in all its aspects; from where the information is taken, which means are used to store it and which means are used to transmit it, as the information must always be appropriately protected. This standard is relevant both to SaMD and SiMD.

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In conclusion, while SaMD operates independently, SiMD is an integrated component of a larger medical device. Understanding these distinctions is essential for both developers and regulatory bodies to navigate the complex landscape of medical device software.