Practically every business now uses software, which has increased the manufacturing and delivery of millions of great products while also bringing new conveniences and complexity levels to products.

The market for medical devices is no exception. Initially, physical devices were operated by software. However, it didn’t take long for people to start developing software-only solutions that had no direct connection to medical device hardware. Even though these products are not standard medical gadgets, they still offer the ability to enhance patients’ overall quality of life. In this article, we want to demystify Software as a medical device (SaMD), give you information about how they’re governed, and let you know what to anticipate when you begin to develop SaMD.

What Is Software As A Medical Device?

SaMD is described by the International Medical Device Regulators Forum (IMDRF) as “software intended for one or more medical purposes that accomplish those objectives without being part of a hardware medical device.”

According to the FDA, SaMD is “software that fulfills the definition of a device in Section 201(h) of the FD&C Act and which on its own is a medical device, and is not integral to a hardware medical device (Software in a medical device).

Additionally, SaMD can be referred to as Clinical Decision Support (CDS) Software if the technology is designed to assist a Health Care Provider in clinical care decision making or referred to as a Digital Therapeutic (DTx) which delivers medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.

The Value of SaMD

Through its accessibility on, for instance, mobile devices, SaMD can simply gather user feedback and swiftly collect enormous volumes of data. This fast-moving feedback loop can speed up product revisions, reduce time to market, and promote innovation for businesses utilizing or developing SaMD.

SaMD can provide more precise treatment options due to it’s data mobility, especially when paired with cutting-edge techniques like AI and robust big data tools to uncover novel clinical insights.

Modern SaMD platforms can enhance care administration and delivery, lower costs, and improve patient outcomes.

Software systems can accurately predict likely progression for chronic disease and help with clinical treatment decision support by utilizing sophisticated algorithms.

For patients with more complex disorders, SaMD can shorten the time between diagnosis and treatment as well as help provide individualized/personalized treatment strategies.

SaMD vs. SiMD: an Important Distinction

There are two distinct types of medical devices: software in a medical device (SiMD) and software as a medical device (SaMD). Only SaMD can run independently.

  1. SaMD: forms a stand-alone medical device that can fulfill one or more medical functions without being a component of a hardware medical device.
  2. SiMD is software that is necessary for a medical device to function properly; it serves no independent medical function. Instead, it works in conjunction with a hardware-based medical device. Despite frequently being assumed to only refer to software that is embedded within medical equipment, this term also refers to mobile, cloud software, and desktop, which are either a component or an accessory of a medical device.

Examples of differences between SaMD and SiMD include:

  • SaMD is software that uses a patient’s food log and data from a blood glucose meter to generate recommendations for insulin dosage for diabetes. The software is a SiMD if it serves as the main display for a specified glucose meter.
  • SaMD is specialized software that tracks a mole for a predetermined amount of time in order to gauge its melanoma risk.
  • SaMD is software that uses MRI analysis to help radiologists and physicians locate and identify cardiovascular conditions. SiMD, on the other hand, is the piece of software that activates and manages the X-ray machine.
  • SaMD is a piece of software that evaluates a patient’s diagnostic data and medical history to establish the proper medication dosage. SaMD or SiMD are not, however, the programs that collect, arrange, or retrieve the actual medical data. An electronic health record (EHR) system, for instance, is not a SaMD or SiMD.

SaMD Regulation

Regulators collectively realized that for stakeholders to promote responsible innovation and safeguard patient safety, best practices guidelines were needed for the SaMD industry.

In order to harmonize medical device regulation, regulators from all over the world formed the International Medical Device Regulators Forum. IMDRF creates documentation that is widely accepted on a range of issues pertaining to medical devices.

The IMDRF formed the SaMD Working Group (WG) in 2013 to promote innovation and speedy access to secure and reliable SaMD worldwide. The group, which was led by the FDA, came to an agreement on the essential specifications for SaMD, as well as the framework for risk classification, quality control, and clinical examination.

Developing SaMD

To optimize patient care and improve outcomes, Innovenn works to build patient-centered SaMD digital health solutions. With more than 125 years of combined expertise, we provide a potent mix of abilities and skills to design, develop, validate, and secure regulatory approvals that enhance patient health.

Innovenn maintains its position as a leader in its industry because of its collaborative culture. We open doors to interdisciplinary collaborations by facilitating the creation and development of innovations that support new drugs, medical equipment, and SaMD all of which are targeted to serve an unmet need and satisfy the particular requirements of the patient.

Our team members are enthusiastic patient advocates who are experts in understanding the requirements for regulatory approval. They have the expertise, credentials, and understanding to collaborate with industry internal stakeholders, HCP’s, advocacy, caregivers and patient groups to collect user input and feedback.


What is software as a medical device?

The FDA defines SaMD as software that fulfills the definition of a device in Section 201(h) of the FD&C Act and which on its own is a medical device, and is not integral to a hardware medical device (Software in a medical device). This comprises computer programs or mobile applications created with the goal of managing, preventing, or curing sickness or other disorders.

What can software as a medical device achieve?

Even if technology won’t replace doctors any time soon, SaMD is still a vital tool for providing patients with improved care. SaMD can speed up the identification, administration, and treatment of numerous medical problems by assisting with areas of care that can be automated utilizing cutting-edge technology.

What is considered software as a medical device?

To qualify as a SaMD, a product’s software must operate independently of any hardware while carrying out the tasks that define it as a medical device. The requirements for SaMD are not met by software that powers hardware or operates a hardware device.

End Note

Software is now a crucial component of many products as technology continues to develop all elements of health care. It is widely integrated into digital platforms for both medical and non-medical uses.

You can choose to engage with and develop SaMD capabilities internally through your own team of subject-matter experts, acquire or contract with businesses that already have SaMD knowledge and expertise, or ignore the effects of the “internet of everything” and risk being disrupted.

Regardless, following SaMD’s best practices benefits everyone by generating better, and safer, products for patients.

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