Complete Guide to Software as a Medical Device

The healthcare sector is rapidly adapting to new technology. On one hand we have the internet of medical things (IoMT) going mainstream with advances in smart medical devices while on the other hand, we have Software as a Medical Device (SaMD) is also growing in popularity.

In this article, we will cover all you need to know about going into building software as a medical device and the regulations you need to be mindful about when doing so.

Classification of medical software

Medical devices are generally classified under four subcategories.

  1. Software as a medical device (SaMD): Standalone medical software without an associated hardware device.
  2. Software in a medical device (SiMD): Software that is integrated into medical equipment or smart medical devices
  3. Software as an accessory to a medical device (SaAMD): The software here functions as an adjuvant to an existing medical device.
  4. General-purpose medical software that isn’t a medical product: These includes

What is software as a medical device

According to the international medical devices regulator’s forum (IMDRF), software as a medical device 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.”

Any software that is an entity on its own without an associated hardware device can be classified as SaMD.

For example, the software that computes the drug dosage based on patient data can be classified as a SaMD whereas a software within a device that dispenses medication is not SaMD.

The U.S. Food and Drug Administration gives a comprehensive listing of what can and cannot be classified as SaMD.

Software as a medical device can range from software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.

The classification of software as a medical device does not depend on where the software runs, whether in the cloud, in a smartphone or a server.

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Applications of Software as a Medical device

SaMD has already found widespread application in the healthcare industry.

It can be deployed across a wide range of devices such as computers, tablets as well as mobile phones. Through its data processing capabilities, SaMD is increasingly being used by healthcare practitioners and the general public alike.

Some of the applications of the SaMD technology include:

  • Preventative health solutions
  • Diagnostic software
  • Chronic disease management software
  • Patient engagement and remote monitoring applications
  • Patient compliance and drug adherence solutions
  • Digital therapeutics

Mobile applications in the health and fitness niche, including diagnostic, preventative, or treatment based apps, all fall under the umbrella of software as a medical device.

A Quick Glance at Software as a Medical Device

Before we dive in, let’s discuss the basics of SaMD:

  • SaMD refers to innovative software used for numerous medical purposes without being interfaced to a hardware device
  • You cannot integrate SaMD devices with an actual medical device
  • SaMD has significant potential for accelerating the growth of the healthcare systems
  • SaMD is not risk-free; instead, it comes with new challenges for regulators and the industries like cybersecurity and tracking

A Quick Overview of the Software as a Medical Device Market

Research reveals that the Software as a Medical Device will likely grow at a remarkable CAGR of 69.3% between 2019 and 2026.

Forbes predicts that 87% of healthcare companies globally utilize IoT services. In addition, organizations have implemented several laws that drive the market growth of Software as a Medical Device.

SaMD vs SiMD

SaMD is a revolutionary standalone medical valuable device for performing various medical purposes. On the other hand, SiMD is a functioning part and does not have medical purposes.

An example of a SaMD is an app that calculates insulin dosages based on a patient’s real-time glucose levels. On the flip side, an example of SiMD is Software integrated within the mobile application used to control medical devices via Bluetooth or Wi-Fi.

Understanding the Four Categories of SaMD

Developers categorize Software as a Medical Device into four main categories based on the level of the impact on a patient’s health:

Category IV

It includes software that can:

  • Calculate fractal dimensions to curate intricate structural maps
  • Perform diagnostic image analysis
  • Combine data to detect mutable pathogens

Category III

It comprises software that can:

  • Detect interrupted or abrupt breathing via general-use products
  • Monitor growth necessary for diagnosing various diseases or skin lesions

Category II

Category two involves software that:

  • Analyze heart rate
  • Integrate tests to identify accurate diagnosis
  • Analyze health data to predict the risk of a particular disease

Category I

It includes software that:

  • Gathers data from symptom journals to identify the risks of occurrence of seizure or asthma episode
  • Analyzes images and eye movement for diagnosing related diseases
  • Stores information about a patient’s vital signs, including blood pressure, glucose level, etc.
  • Aids in self-assessment

What are the Key Functionalities of SaMD

The features of a SaMD vary depending on their medical purpose and target audience. Here we discuss the general functionalities of a Software as a Medical Device:

User Functionality for Patients

With SaMD, users can offer the following critical functionalities for patients:

  • Identifies abnormalities, such as erratic breathing or shooting blood pressure
  • Measuring health parameters by leveraging general electronics, like smartphones
  • Image analysis and comparison, including photos of moles for effectively assessing risk
  • Analyzing external data to prevent symptoms
  • Offering therapeutic interventions, such as video therapy or sound therapy for anxiety

User Functionality for Medical Staff

SaMD offers healthcare providers the following functionalities:

  • Analyzing patient’s health by accessing in-depth data to detect diseases
  • Leveraging complex SaMD algorithms to calculate and curate treatment plans
  • Accessing SaMD-powered recommendations for diagnosing, treating, and managing diseases
  • Adjusting medical images to ensure accessibility on general-purpose devices like tablets, laptops, and smartphones

Cloud Data Storage and Exchange of PHI

SaMD also offers the following additional functionalities:

  • Collecting, analyzing, and transmitting critical clinical data from integrated healthcare IT systems; thus boosting interoperability
  • Storing and exchanging medical images while complying with DICOM standards
  • Downloading a patient’s public healthcare information to access a patient’s heart-rate statistics, drug dosage intake, and more

Security and Regulatory Compliance

SaMD ensures top-notch security by requiring users to adhere to stringent guidelines:

  • Role-based access control
  • HITECH, HIPAA, FDA, and ONC compliance
  • Requires two-factor user authentication for patients and healthcare providers alike
  • Strong passwords to access Public Health Information (PHI)
  • Data encryption to avoid data breaches
  • Automated identification of unauthorized sessions

SaMD Guides for Users

It includes:

  • Easy-to-understand instructions to help users learn SaMD functionalities
  • Inline suggestions for challenging data input


SaMD also facilitates marketing, such as:

  • Managing and improving customer loyalty
  • Utilizing feedback surveys to analyze and enhance Software as a Medical Device

Creating a Roadmap for Developing a Software as a Medical Device

There’s no doubt that healthcare organizations have the regulatory expertise to develop, launch, and distribute medication. But when it comes to digital health products, your company requires a unique skill-set.

Creating SaMD solutions is a complex process that requires healthcare software developers to prepare a regulatory roadmap to ensure that you know:

  • What you’ll require
  • How you’ll achieve a specific task
  • How much time you’ll need to roll out your SaMD solution

While the requirements of SaMD are consistent because of regulatory standards, getting each process right demands careful planning. It includes market-specific approaches, leveraging proven techniques, and classifying the software under MDR.

Ensure that you include the concept of intended use in your regulatory roadmap, primarily since digital health devices will likely evolve based on patient and clinician feedback. In addition, highlighting the intended use provides you with a clear statement of intent for your solution.

What are the Benefits of Software as a Medical Device?

The flexibility and versatility of Software as a Medical Device accelerates innovation in various other healthcare domains, including medical treatment and techniques.

With the help of SaMD, healthcare professionals can collate data from various sources that are useful for:

1. Innovating Screening and Diagnosis

Software programs leverage complex algorithms to predict the risk of chronic diseases efficiently. It also aids in delivering personalized treatment plans by giving medical providers an insightful look at a patient’s medical condition.

With SaMD, clinicians can access a holistic view of a patient’s medical conditions, family history, and real-time statuses. Moreover, it effectively reduces the time necessary to diagnose and treat a patient accurately.

2. Enhancing Monitoring and Alerting

Software as a Medical Device is a valuable tool for designing wearable sensors to detect a patient’s vital signs.

SaMD effectively monitors and leverages this data to enable targeted recommendations for patients and clinicians. As a result, it helps enhance a patient’s adherence to treatment and improve clinical outcomes.

3. Offering Digital Therapeutics

Software as a Medical Device enables patients and clinicians to track necessary health data. Medical providers can tweak treatment plans using this data to be increase effectiveness and patient-centric care.

Since SaMD allows patients to monitor and interpret their health activity, it enables them to take ownership of treatment decisions.

4. Improving Chronic Condition and Disease Management

SaMD plays a critical role in alleviating the symptoms of chronic illnesses by generating essential data in medicinal products and medical devices and providing therapy to patients’ bodies.

Moreover, it enables healthcare practitioners to provide cutting-edge treatment management to patients with complex and chronic diseases.

5. Identifying Trends

SaMD helps identify patterns and trends in collected data allowing users to identify areas for improvement. It can also effectively spot potential casualties.

Challenges of Software as a Medical Device

While SaMD helps enhance health outcomes by collecting crucial data and speeding up feedback loops, it also poses numerous fundamental challenges for SaMD builders.

The biggest challenge of Software as a Medical Device is integrating it within modern product development methodology. However, it seems impossible to infuse ever-evolving tech with patient safety and stringent regulations, organizations that achieve this benefit immensely.

The FDA also faces various challenges, such as difficulty ensuring patient safety and organizational effectiveness without risking innovations. Remember that there is no universal set of rules for developing SaMD.But it’s always better to start with pilot programs while leveraging fast feedback loops.

Looking at Some Examples of Software as a Medical Device

Software as a Medical Device is of diverse types, such as software that enables smartphones to view MRI images for diagnostic purposes to perform post-processing to detect cancer.

Here we discuss the top examples of Software as a Medical Device:

  • Developers can interface SaMD with other medical devices, such as general-purpose software, hardware medical devices, and other software. For instance, treatment planning software may supply relevant information by employing a linear accelerator is Software as a Medical Device
  • Software as a Medical device may also include a general-purpose computing platform employed as a medical device. For instance, software created for diagnosing a condition with the help of a tri-axial accelerator that operates on a computing platform counts as a SaMD
  • Software connected to hardware medical devices that is not an integral part of the hardware medical devices to achieve medical purpose is also Software as a Medical Device

And Some that Are Not

Here we’ve listed some examples that are not SaMD:

  • Software necessary for driving or controlling motors and the pumping of medication
  • The software involved in closed-loop control in hardware medical devices
  • Software required by hardware medical devices to achieve its intended use
  • Software that relies on medical devices to source data but does not have a medical purpose
  • Software that monitors performance and functioning of a device for servicing devices, such as tools that monitor x-ray tube performance
  • Software that analyzes laboratory quality control data to identify random errors and potential outcomes
  • Software that promotes clinical communication and enhances workflow

Who regulates software as a medical device?

The international medical devices regulator’s forum (IMDRF) and the Food and Drug Administration (FDA) are the two entities that look at approving and regulating software as a medical device.

The IMDRF presents information on SaMD classification, including the responsibilities of a manufacturer, risk categorization, quality management systems as well as labelling, instruction standards and clinical evaluation for this software.

The SaMD working group (WG) chaired by FDA was formed in 2013 to develop guidance supporting innovation and bolster the timely availability of SaMD on a global scale.

How Does the FDA Software Pre-Certification Program Facilitate SaMD?

Software and, in particular, SaMD boasts tremendous potential for increasing the quality and efficiency of care.

To accelerate the growth of computing platforms and connectivity, the FDA developed a Software Pre-certification that addresses the following pain points:

  • Determining the best ways to apply iterative design methods in the development of software
  • Ways to collect health data inside and outside hospitals to address patient’s problems quicker and more efficiently
  • Identifying how to enhance product performance in less time
  • Creating an agile regulatory model that supports the innovation of software-based products while ensuring high safety standards

FDA’s Pre-certification Program serves as a test and offers the following benefits:

  • Enhanced clarity of oversight and approach to a specific technology
  • Developing an efficient, risk-based regulatory framework
  • Expanding FDA’s digital health unit
  • Enabling faster patient access to tech

FDA guidelines for developing SaMD

Responsibility of compliance

The legal responsibility for ensuring compliance with the regulatory norms lies with the manufacturer of the SaMD.

These include both pre-market requirements such as adherence to stringent quality measures as well as post-market regulations such as reporting of adverse events and corrective actions.

Labels and intentions for use

The recommendations and intended purpose of use of the software need to be explicitly stated and attached with the software. The potential adverse consequences should also be outlined by the manufacturer.

Supporting clinical vocabulary

Software as a medical device needs to have supportive clinical vocabulary and linguistic design in the interface in order to expel any room for error within the resultant application.

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Software maintenance

Any modifications made in the SaMD lifecycle including the maintenance phase fall under SaMD changes. These changes can fall under the following categories

  • preventive- correction of latent faults before they become operational faults,
  • corrective- set right the problems discovered within the software,
  • adaptive- keeping pace with the changing environment, and
  • perfective- improving existing performance.

Framework components for modernizing Software as a Medical Device regulations

FDA is currently working on modernizing the SaMD regulations which comprise of the following three core components.

Regulatory development kit

The RDK is a software module that gives the users a step-by-step process to guide them through the regulatory process. It contains tools to clarify the requirements at every stage of the process and provide answers to the frequently asked questions.

It can also function as a platform for discussing best practices across domains, thus pioneering innovation in the healthcare industry.

FDA pre-certification program

The pre-cert program is a risk-based and organized approval process for the healthcare organizations that exhibit a commitment to quality and excellence.

Software developers get access to the key pre and post-market information thus accelerating the process for them.

Since the level of level is computed, the regulatory requirements are modified on the basis of risk computation. Consecutively, higher risk products would have greater requirements than their lower risk counterparts.

Real-world data capability

SaMDs connect to the internet to collect the real-world clinical as well non-clinical data across a large number of data points. SaMD can analyze the collected data to iterate on the device, helping make it more accurate, intelligent, and patient-centered.

Stringent data security norms need to be in place while collecting, storing and analyzing patient data in order to conform to the HIPAA privacy and security rule.

What lies ahead

As innovations continue to power up the field of SaMD, partnering with an experienced healthcare software development company like Arkenea, that are well versed with the stringent data protection requirements and HIPAA regulations can flatten the learning curve and get you better poised for success.

Arkenea is a pioneer in the development of healthcare software with a decade of core healthcare industry experience. Have a healthcare project you need to discuss? Get in touch with us for a free consultation and estimate.