The world of medical devices is no longer limited to physical instruments and implants. Software is now a huge aid in healthcare, from diagnosing diseases to managing chronic conditions. This has led to an important regulatory category known as Software as a Medical Device (SaMD).
Understanding what SaMD is, how it differs from other medical software, and how it is regulated is very important for any technology company operating in the digital health space. The development of Software as a Medical Device (SaMD) requires a unique approach to quality management, one that blends the rigor of medical device regulations with the speed and agility of modern software development. This guide will provide a clear definition of SaMD, offer real world examples, and explain the regulatory frameworks you need to know.
Table of Contents
What is SaMD? (IMDRF Definition)
This section defines SaMD according to the official international framework. It clarifies that SaMD is a medical device in its own right, distinct from the hardware it runs on.
The official definition for Software as a Medical Device (SaMD) comes from the International Medical Device Regulators Forum (IMDRF), a global group of regulatory authorities. The IMDRF defines 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.”
This definition contains two critical concepts. First, the software must have a “medical purpose.” This means it is intended to be used to diagnose, cure, mitigate, treat, or prevent a disease. Software for general wellness or lifestyle purposes, like a fitness tracker, is typically not considered SaMD. Second, the software must perform this medical purpose “without being part of a hardware medical device.” This is what makes Software as a Medical Device (SaMD) unique. The software itself is the medical device. It is not an accessory to a physical device, nor is it the firmware that makes a physical device run. It is a standalone software application that executes on general purpose hardware, such as a smartphone, a tablet, or a cloud server.
Understanding this official definition is the first step for any developer or company to determine if their product falls under this specific regulatory category, which has its own set of rules and expectations.
How to Tell If Your Software Is SaMD or SiMD
One of the most common points of confusion is the difference between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). They are regulated differently, and getting the classification right is an important early step that will influence your entire QMS implementation strategy.
Software in a Medical Device (SiMD) is software that is an integral part of a physical medical device. It is needed for the hardware to function. Think of the software that controls an MRI machine, the firmware inside an infusion pump, or the code that runs a pacemaker. This type of software is considered a component of the hardware device, and it is regulated as part of that device. You cannot separate the software from the hardware.
Software as a Medical Device (SaMD), on the other hand, is a standalone product. It runs on non medical computing platforms and performs a medical function on its own. It is not needed to make a piece of hardware work. The key question to ask is “Is the software a component of a physical device, or is the software the device itself?” The answer determines whether you are dealing with SiMD or SaMD.
Here is a simple way to think about the distinction:
- Software that controls a motor in a medical device: This is Software in a Medical Device (SiMD). The motor and the software are part of one physical device.
- Software on a smartphone that analyzes a picture of a mole for signs of cancer: This is Software as a Medical Device (SaMD). The smartphone is general purpose hardware, and the software itself is performing the medical diagnosis.
- Software that takes blood glucose readings from a specific, connected meter and displays them: This could be SiMD if it is required for the meter to function, or it could be an accessory to a medical device.
- Software on a cloud server that analyzes patient data from an electronic health record to predict the likelihood of a disease: This is a classic example of Software as a Medical device (SaMD).
Real World Examples of SaMD
The applications for Software as a Medical Device (SaMD) are growing rapidly and cover a wide range of medical purposes. These examples show the diversity of this innovative field.
- Diagnostic Image Analysis. This is one of the most common categories. It includes software that uses an algorithm to analyze medical images, such as CT scans, MRIs, or X rays, to help clinicians detect conditions like tumors, strokes, or fractures. The software isn’t part of the imaging machine, it’s a separate program that analyzes the output.
- Treatment Planning Software. This type of Software as a Medical Device (SaMD) helps clinicians plan and optimize treatments. Examples include software that calculates the precise radiation dosage and trajectory for cancer therapy or software that creates a surgical plan based on a patient’s anatomical data.
- Chronic Condition Management. Many mobile applications that help patients manage chronic diseases fall into this category. For example, an app that analyzes a diabetic patient’s logged glucose levels, diet, and exercise to provide insulin dosing recommendations would be considered Software as a Medical Device (SaMD).
- Screening and Triage Software. This includes software that uses patient reported symptoms or data from a smartwatch to screen for a condition and recommend a course of action. An app that analyzes a person’s speech patterns to screen for signs of cognitive impairment is another example.
- Data Analysis and Prediction. This category includes powerful software that analyzes large datasets to diagnose a condition, and these complex algorithms are under intense scrutiny from regulations like the EU MDR.
Key Regulatory Bodies & Frameworks
The regulation of Software as a Medical Device (SaMD) is an ever changing area, and a key part of audit management in life sciences is staying current with the principles established by the IMDRF. National regulatory bodies then adapt these principles for their own regions.
IMDRF
The International Medical Device Regulators Forum has been the driving force behind creating a common approach to SaMD Regulation. The IMDRF has published several key guidance documents that define what SaMD is, establish a risk categorization framework based on the software’s impact on patient health, and outline the clinical evaluation requirements for these products. This risk framework is a key concept in all modern medical device regulations.
FDA
In the United States, the Food and Drug Administration (FDA) regulates SaMD as a medical device. The FDA has been a leader in developing a modern SaMD regulation approach for digital health products. They have largely aligned with the IMDRF’s risk based framework and have created a Digital Health Center of Excellence to manage the growing number of submissions. While the FDA has its own QSR (21 CFR 820), the importance of ISO 13485 in medical device development is globally recognized and provides a strong base for meeting FDA requirements.
EU MDR
In the European Union, Software as a Medical Device (SaMD) is regulated under the Medical Device Regulation (MDR). The EU MDR has strict requirements for medical devices, including software. Under the MDR, SaMD is classified according to its risk level, and manufacturers must have a certified Quality Management System, typically with ISO 13485 compliance, and provide extensive clinical evidence to prove the software is safe and performs as intended. The path to SaMD Regulation in Europe is very demanding.
Why a QMS Is Critical for SaMD Compliance
For any medical device, a Quality Management System (QMS) is a legal requirement. The same is true for Software as a Medical Device (SaMD). However, the nature of software development requires a QMS that is both rigorous and agile. Trying to develop software using a traditional, paper based QMS is incredibly inefficient and slows down innovation.
A modern QMS in medical device development can manage the entire product lifecycle in a compliant way. It manages design controls, risk management according to ISO 14971, document control for all specifications and plans, and the entire software validation process. It helps automate the creation of the design history file (DHF) and guarantees that all activities, from bug tracking to release management, are fully traceable and audit ready..
How AI-Powered QMS Tools Enhance SaMD Quality
The development and post market surveillance of Software as a Medical Device (SaMD) generates a huge amount of data. This is where an AI powered QMS can provide a huge advantage. AI tools can analyze post market surveillance data and user feedback to identify emerging issues or trends that might indicate a problem with the software’s algorithm or usability. This allows for a more proactive approach to updates and risk management. During development, AI can assist in analyzing the complexity of code changes and predicting their potential impact on other parts of the software, helping to focus testing efforts where they are most needed. AI can also streamline audit management by helping to quickly find records and analyze compliance data. A key part of Software as a Medical Device (SaMD) is addressing the challenges in SaMD and an AI QMS can help you get ahead of them.
Conclusion
Software as a Medical Device (SaMD) represents a new frontier in healthcare, offering incredible potential to improve diagnosis and treatment. It also comes with a serious responsibility to support patient safety and clinical validity. Figuring out SaMD regulation requires a deep understanding of the rules and, most importantly, a robust and agile Quality Management System.
At Quality Forward, we provide a modern, cloud native eQMS designed to meet the unique needs of medical device companies, including those developing innovative SaMD products. Our system is built to support agile development methodologies while supporting full compliance with standards like ISO 13485 and FDA 21 CFR Part 11. If you are developing a SaMD product, contact us to learn how our QMS can help you accelerate your path to market while upholding the highest standards of quality and compliance.
