Medical Device Software & SaMDs: A Crash Course

When it comes to evolution, the technology always has the lead. With new ideas emerging nearly every day on the face of the world, technology keeps reshaping our lives, and innovations and software applications are one prime example of that. Whether it is economic, social, educational, or medical, software programs and applications are helping human beings in every aspect of life.

The field of medical science has seen many great advancements, especially in the past few decades. Nowadays, different software applications are helping the medical personnel in not only diagnosing but also in the treating healthcare conditions. These software programs can determine the prognosis, spread, and other factors related to the diagnosis of a disease and can also provide with necessary steps that are required to treat them.

Some examples of these modern software programs are Viz LVO that can help in the identification of a stroke that is caused by Large Vessel Obstruction (LVO). The DreaMed Advisor can provide decision support for those suffering from diabetes. IDx-DR can make autonomous decisions regarding the issues related to ophthalmology without the help of human oversight.

These and many other software programs are helping medical practitioners worldwide. All of this sophisticated software programs are assisting in diagnosing, treating, and controlling different acute and chronic conditions. The monitoring process is ensured by establishing strong communication between both patient and the doctor.

Interaction of Different International Standards for Software Development:

In the modern world of today which is almost entirely digital, medical devices are either incorporated with a software component or are comprised totally of a stand-alone software on a mobile device. This is known as Software as a Medical Device (SaMD). SaMDs are usually connected with a database of medical devices from where they receive data.

Regarding the development and implementation of medical device software, ISO and IEC have devised various standards.

The ISO 62304:

The ISO 62304 specifies life-cycle requirements for the medical software and other software within medical devices. This standard helps to provide the base for the development of medical devices.

ISO 14971 & ISO 13485:

Both of these standards provide a management system for the development of medical devices.

IEC 60601-1 & IEC 60601-2:

Once the software’s interaction with the medical device is determined, IEC 60601-1 and IEC 60601-2 ensure safety requirements that are related to the electrical equipment.

Implementation of Medical Device Software:

For the implementation of medical device software, the ISO 62304 provides basis for development and maintenance of a safe software development system. This developmental procedure requires a proper management environment that is provided with ISO 13485 and ISO 14971. The ISO 13485 provides with a Quality Management System while ISO 14971 helps in the application of risk management system. All of these three standards help in building a foundation to develop medical devices.

The three standards provided by International Electrotechnical Commission i.e. IEC 60601-1, IEC 61010-1 and IEC 60601-2. The first two IEC standards focus on the medical electrical equipment safety and electrical equipment safety requirements respectively while the IEC 60601-2 emphasizes on medical electrical particular requirements.

All of these standards when come into action together, help in the implementation of medical device software.

The IEC 62304 and FDA Concerns:

The IEC 623404 deals with the software lifecycle processes. It helps in the identification of various models of software development with different classifications. This classification model complies with FDA concerns. IEC 62304 classifies medical software in three safety classes.

IEC and FDA Classification of SaMDs and Medical Devices:

According to IEC 62304, there are 3 classes of medical devices i.e. Class A medical devices, Class B medical devices and Class C medical devices. This classification is further divided by FDA on the level of concern in terms of the impact they have on human lives.

A class A medical device software or SaMD does not have the possibility of imposing damage on the human life therefore, FDA has minor level of concern for such devices.

A class Bmedical device software or SaMD can be a source of a possible non-serious injury and therefore, the FDA’s has a moderate level of concern for class B devices.

The medical device software or SaMD falling in class C category is considered as the most lethal and FDA shows major concern for the software and SaMDs falling into this category.

SaMDs Classification:

SaMD classifies software as a medical device based on the risk they possess on a patient’s health. The devices which are completely harmless such as a BMI calculator will require very little documentation whereas a medical device that emits a large number of radiations to scan soft tissues and bones requires rigorous documenting.

Thus the medical device software and SaMDs manufacturers are required to keep themselves in constant contact with the FDA, so that they can keep themselves up-to-date with the ever-changing standards and regulations.


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