This article describes Software Based Medical Devices and their key regulatory considerations.
Table of Contents
Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital platforms for both medical and non-medical uses.
One of three forms of software connected to medical devices is software that, on its own, qualifies as a medical device.
Software that is part of a medical device (software in a medical device) and software used in the creation or upkeep of a medical device are the other two categories of software connected to medical devices.
Differentiating between standalone medical software (SaMD) and software integrated into medical devices is crucial.
SaMD is software designed for medical use on standard computing platforms or mobile devices. It has specific regulatory requirements like validation, clinical evaluation, and post-market surveillance.
Software-based Medical Devices
As per the International medical device regulatory Forum (IMDRF), “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Key Points:-
- SaMD is a medical device and includes an in-vitro diagnostic (IVD) medical device.
- SaMD is capable of running on general purpose (non-medical purpose) computing platforms3
- “Without being part of” means software is not necessary for a hardware medical device to achieve its intended medical purpose.
- Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
- SaMD may be used in combination (e.g., as a module) with other products including medical devices.
- SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general-purpose software
- Mobile apps that meet the definition above are considered SaMD.
Classification of Software Based Medical Devices
Medical devices are categorized by regulatory bodies according to their associated risks, falling into classes from class I (low risk) to class III (high risk).
Software medical devices are classified based on their purpose, duration, invasiveness, and safety impact, and this classification dictates the required regulatory process and standards.
Regulatory Landscape
Developers and manufacturers of software-based medical devices must navigate various regulatory frameworks to ensure compliance.
The regulatory landscape is typically governed by organizations such as the U.S. Food and Drug Administration (FDA), the European Union’s Medical Device Regulation (MDR), and other national regulatory bodies worldwide.
Understanding these regulations is essential to meet safety, efficacy, and quality standards.
The International Medical Device Regulators Forum (IMDRF) established a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness, and performance of SaMD.
Key Features of Software Based Medical Device Management
Quality Management Systems (QMS)
Building a strong quality management system (QMS) is crucial for developing software-based medical devices. Adhering to standards like ISO 13485:2016 ensures controlled and traceable development, testing, and maintenance. A comprehensive QMS includes risk management, software development, documentation, configuration management, and validation.
Risk Management
Software medical devices require thorough risk management, involving analysis, evaluation, control measures, and post-market surveillance. Given software’s dynamic nature, continuous risk management is vital across the device’s lifecycle.
Clinical Evaluation and Validation
Clinical evaluation is vital for proving the safety, performance, and purpose of software medical devices, involving data collection and analysis. Validation, in contrast, verifies that the software functions as intended in its designated environment.
Post-Market Surveillance
After a software-based medical device is in the market, post-market surveillance continuously monitors its performance, safety, and usability. Developers and manufacturers gather and analyze post-market data, address incidents, and make necessary improvements. This proactive surveillance enhances device safety and user satisfaction..
Conclusion
To navigate the evolving landscape of software-based medical devices, manufacturers should prioritize regulatory compliance, quality systems, cybersecurity, and communication with regulators. This commitment ensures device safety, effectiveness, and regulatory adherence, benefiting both patients and the healthcare industry.
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