- What is medical device software development?
- What are the different types of medical device software?
- How to know if your software is a medical device?
- What are the standards and regulations for medical device software?
- What is the medical device software safety classification?
- What does the software development process for medical devices entail?
What Is Medical Device Software Development?
Medical device software development is a structured process, from design build to long-term maintenance. Because software performance can have a direct impact on patient health, its development is highly regulated and subject to strict requirements for safety, quality, and reliability.
Ultimately, the goal of the development process is to create reliable medical device software that meets regulatory expectations and delivers experience that enables users to carry out their tasks with confidence.
The Role Of Software In Modern Healthcare
Software now plays a central role in the way care and related services are delivered, monitored, and supported. Healthcare professionals, whether in hospitals, clinics, or home-care settings, have become accustomed to using digital tools to make informed medical decisions, automate repetitive tasks, and access important information at the right time.
What Are the Different Types of Medical Device Software?
Software as a Medical Device (SaMD)
A Software as a Medical Device (SaMD) is a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”, according to the International Medical Device Regulators Forum (IMDRF). SaMD includes standalone applications such as mobile apps, cloud-based tools, and desktop applications designed for medical purposes. These solutions function independently from specialized medical hardware and can operate on general-purpose computing platforms like smartphones, tablets, or personal computers.
Software in a Medical Device (SiMD)
How to Know If Your Software Is a Medical Device?
The first step is to determine whether your software qualifies as a medical device. To do this, you must clearly define its intended use and indications for use. Once these parameters are established, you can evaluate if your software meets the definition of a medical device.
According to the FDA, a medical device is a device “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals”.
Additionally, searching for existing product classifications relevant to your software can be helpful. Finding a classification that aligns with your software’s intended use is a strong indication that it could be a medical device.
What Are the Standards and Regulations for Medical Device Software?
Due to their significant impact on clinical outcomes, custom software medical devices must undergo rigorous development processes guided by standards and regulations.
These regulations and standards ensure safety, effectiveness, and security. They provide a framework that includes best practices for organizational structure, project management, risk management, as well as design, implementation, verification, and validation processes.
IEC 62304 Standard for Medical Device Software Development
IEC 62304 is a reference for the medical device software development lifecycle, focusing on the safety of these systems.
It specifies required activities for each process of the software lifecycle based on the risk level the software presents to patients and users. It establishes a software safety classification system that divides medical software into three safety classes. As the risk level increases, so too does the number of required activities.
The 3 medical software safety classes according to IEC 62304:
- Class A: No possibility of injury or damage to the patient.
- Class B: Potential for injury, but not severe.
- Class C: Potential for severe harm or death.
Custom medical device software developed in accordance with these standards is more likely to comply with current international regulations and achieve market approval.
Quality Management System (QMS): A Mandatory Requirement
In the context of medical device development, establishing and applying a QMS is a mandatory requirement. The ISO 13485 standard, titled “Medical devices – Quality management systems”, outlines the requirements for quality management systems in medical devices development, but is not specific to any discipline. IEC 62304 complements ISO 13485 by providing requirements for software development.
Cybersecurity Risk Control
Medical device software is connected to the Internet, hospital networks, and other medical devices, increasing potential cybersecurity risks. While IEC 62304 doesn’t address cybersecurity activities, FDA guidance provides recommendations for considering cybersecurity in premarket submissions.
During the software development process, it’s crucial to identify, analyze, evaluate, and control cybersecurity risks associated with the intended use.
“Robust risk control measures, such as data encryption, multi-factor authentication, and strict access controls, must be implemented during the software development process, as well as security audits and penetration testing during and after the development. They are vital to safeguard software against the growing prevalence and complexity of cyber attacks.”
Patient Data Protection
In the sensitive context of healthcare, ensuring patient data protection is essential from the earliest stages of medical device software development. Mechanisms must be incorporated to guarantee the confidentiality and integrity of patient information.
Software Safety Classification: Understanding Risk Levels
The IEC 62304 standard provides a structured approach to software safety classification, dividing medical device software into three distinct classes based on the potential risk to patients and users:
- Class A: Device software that cannot cause injury or harm to the patient or user, even in the event of a failure. For example, a heart rate monitoring app that simply displays data without making treatment decisions would typically fall into this category.
- Class B: Device software where a failure could cause non-serious injury. An example might be software that provides dosage recommendations for non-critical medications.
- Class C: Device software where a failure could result in serious injury or death. This includes software that controls life-sustaining devices, such as pacemakers or infusion pumps.
The Software Development Process for Medical Devices
Medical device software undergoes the same development phases as any other type of software; however, it requires particular emphasis on compliance with specific standards and guidelines, which vary according to the software’s classification.
Here are the six steps involved in developing software for medical devices:
1. Planning and Defining Requirements
2. Architecture and Detailed Design
3. Development and Coding
4. Testing and Verification
Medical software must undergo a series of rigorous tests to ensure it meets all safety, functionality, and performance requirements. This includes unit testing, integration testing, performance testing, and system testing.
5. Release
6. Post-Market Monitoring
Build Your Medical Devices With CLEIO!
Collaborate with our experienced team of 50+ experts and build software that meets industry standards while delivering reliable, effective care.
FAQ About Medical Device Software Development
What is the difference between software verification and validation in medical device development?
What documentation is required during software development according to IEC 62304?
What is post-market surveillance for medical device software?
How are software updates managed in regulated medical device products?
What role does human factors engineering play in software development?
What is design input/output traceability in medical software development?
Why is interoperability testing important for medical device software?
What cybersecurity controls are mandatory during medical device development?
Controls include authentication, access restriction, encryption, threat modeling, and secure update mechanisms aligned with FDA premarket guidance.