What is Software as Medical device and why it matters
Andi Nicolescu
CTO
Reading time: 6 min
Published: Oct 28, 2021
Key takeaways
- Software as a medical device (SaMD) is software intended for medical purposes that performs those purposes without being part of a hardware medical device, as defined by the IMDRF.
- SaMD is distinct from software in a medical device (embedded in hardware) and software used to manufacture or maintain a medical device.
- In the EU, SaMD is regulated under the Medical Device Regulation (MDR 2017/745) or IVDR 2017/746, while in the US it falls under FDA oversight and is risk-classified before market clearance.
- Medical device software development should follow the IEC 62304 software life cycle standard and a quality system such as ISO 13485 or the FDA's 21 CFR Part 820.
- Common SaMD examples include diagnostic imaging analysis tools, symptom-monitoring mobile apps, chronic disease management platforms, and digital therapeutics.
Emerging technologies and digitalization have a huge impact on the healthcare industry. They streamline processes and increase transparency. They also ease communication between all parties, store patient data more securely, improve response times, and support quick diagnoses.
Software is the core of many MedTech apps and HealthTech solutions. It is built into a wide range of products and platforms, whether medical or non-medical.
Search the internet and you’ll find many terms for software as a medical device. You may see “medical device samd,” “samd software,” and more. Don’t worry: they all relate to the “Software as a Medical Device” term.
Let’s see how Software as a Medical Device plays an important role in patient safety, patient data, and overall patient health.
What types of software solutions are related to medical devices?
There are three types of software solutions related to medical devices:
- Software as a medical device (samd software)
- Software in a medical device
- Software used in the manufacture or maintenance of a medical device
We’ll go through each type. You’ll see what it means, how it fits into healthcare, and how providers can get the most from it while keeping patient safety first.
What is Software as a Medical Device, and how can you use it?
The International Medical Device Regulators Forum (IMDRF) defines Software as a Medical Device as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
To put it plainly, Software as a Medical Device can be a mobile app or any other software that helps patients on its own. It works independently from other hardware medical devices. It can use data from a device, but it is not connected to it.
Think about the software that helps medical staff analyze X-rays and MRIs. There are plenty of devices to take a scan. There are also plenty of software solutions that help you diagnose conditions from the results.
Software as a Medical Device examples:
- Software used for screening, diagnosis, treatment, relief, or prevention of different conditions.
- Mobile apps for patient registration, symptom and health monitoring, pain alerts, arrhythmia management, and blood glucose monitoring.
- Apps for chronic condition and disease management.
- Any web or mobile solution used for digital therapeutics.
What is Software in a Medical Device, and how common is it?
Software in medical devices has become more common. Advances in technology and the drive to improve functionality, connectivity, and usability all play a part.
Software in a medical device is any software function or app that is an integral part of a device’s functionality, control, or data processing. It can cover a wide range of components. These include embedded firmware that controls device operations, user interfaces, data processing algorithms, and communication protocols.
For example, consider software that helps radiologists diagnose conditions from a scan. Or software that turns MRI magnet signals into an image you can look at. If we mean an interface to control the device, then we are looking at Software in a Medical Device.
Software used in the manufacture or maintenance of a medical device
This is medical software used in the production, quality control, testing, and ongoing upkeep of medical devices. These tools play a key role in ensuring devices are safe, effective, and compliant with medical device regulations.
Here are some examples of software used in this context:
Computer-Aided Design (CAD) Software: CAD software supports the design and development of medical devices. Engineers and designers use CAD tools to create detailed 2D and 3D models. This helps them visualize and refine designs before production.
Computer-Aided Manufacturing (CAM) Software: CAM software generates instructions for manufacturing processes like CNC machining or 3D printing. It translates CAD designs into precise instructions for machinery.
Quality Control and Testing Software: This category covers software for tests, inspections, and quality checks on medical devices. It ensures devices meet the required standards and regulations.
Validation and Verification Software: These tools help confirm that a device works correctly and meets its design specifications. They are essential for device safety and reliability.
Regulatory Compliance Software: Regulators like the FDA (U.S. Food and Drug Administration) require extensive documentation and reporting. This software manages regulatory compliance, including electronic record-keeping and reporting.
Risk Assessment and Management Software: This software helps assess and manage the risks tied to medical devices. It ensures potential hazards are identified and reduced.
Change Management Software: When a device is modified or updated, this software tracks and documents the changes. It ensures they are properly evaluated and implemented.
Asset Management and Maintenance Software: This software tracks and manages the maintenance and calibration of manufacturing equipment and devices in healthcare facilities.
Electronic Document Management Systems (EDMS): EDMS software stores, organizes, and manages the extensive documentation needed to make and maintain devices. This includes design records, test reports, and regulatory submissions.
Simulation and Modeling Software: Engineers and researchers use this software to simulate how devices behave under various conditions. It can help optimize device designs and performance.
Supply Chain and Inventory Management Software: This software tracks and manages inventory levels. It helps ensure the components and materials needed to make devices are available.
Data Analytics and Reporting Tools: These tools analyze data from the manufacturing process or from post-market surveillance. They can spot trends, potential issues, and chances to improve.
The rise of software in medical devices has drawn more scrutiny from regulators like the FDA. Manufacturers must follow strict regulations and standards, such as the FDA’s Quality System Regulation (21 CFR Part 820). Software developers also need to follow the International Electrotechnical Commission (IEC) 62304 standard, which addresses software life cycle processes for medical device software.
Build your Software as a Medical Device with us
We have deep expertise in the healthcare industry and public health. Check our projects page to see the digital products we’ve built over the years. We recommend looking at BrainCapture, an app certified as software as a medical device.
We have what it takes to build digital health apps for prevention, diagnosis, intervention, treatment, recovery, and patient management and communication. We look forward to working on the next meaningful medical software, especially in these times.
We really know how to work with health professionals!
Do you have a healthcare startup? Are you looking to digitalize any healthcare services or any part of the Medical Act? Get in touch with us, and let’s talk!
