The landscape of healthcare technology is ever-changing, it’s an industry where innovation and patient care intersect, hence why the development and deployment of medical device software is of extreme importance. Maintaining the safety, efficacy, and dependability of software utilized in medical devices requires strict adherence to standards that are in harmony with the crucial healthcare context. In the midst of these standards, IEC 62304 stands as a key foundation, it lays out a structured framework for the development, maintenance, and lifecycle management of medical device software.
In this blog post we cover different aspects of this standard that regulates software life cycle processes. We cover things such as what it is, the general requirements, the software development process, the maintenance process, and how we apply all of this to our work.
What is IEC 62304?
Software frequently plays an essential role in medical device technology. Ensuring the safety and efficacy of medical devices incorporating software necessitates a deep understanding of the software's intended functions and a demonstration that its use achieves these goals without introducing any undue risks.
IEC 62304, established by the International Electrotechnical Commission (IEC), is a globally acknowledged standard. This standard is tailored to address the lifecycle processes associated with the development, maintenance, and management of medical device software. It lays out a well-defined framework and guidance to guarantee the safety, efficacy, and dependability of software incorporated into medical devices, all of which hold paramount importance within the healthcare sector.
This standard establishes a comprehensive framework for the lifecycle processes, encompassing essential activities and tasks crucial for the secure design and upkeep of medical device software. It delineates specific requirements for each lifecycle process, further breaking down these processes into a series of activities, and in many cases, subdividing these activities into specific tasks.
This standard applies to several types of medical devices that incorporate software, ranging from simple standalone software applications to complex software-driven medical systems. Adhering to IEC 62304 standard it helps manufacturers, developers, and regulatory bodies make sure that medical device software meets the required quality and safety standards, which contributes to the overall patient safety and well-being.
IEC 62304 latest version plays a pivotal role in steering the development of medical device software, facilitating adherence to regulatory mandates, and cultivating a culture of excellence and responsibility within the healthcare technology field.
Software development process according to IEC 62304
IEC 62304 standard lays out the stages and activities that should be acted in accordance with throughout the software development lifecycle, this includes design, development, testing, deployment, and post-market surveillance. It establishes requirements for documentation, risk management, validation, and verification processes to minimize the potential risks associated with medical device software.
Some of the general requirements for the software development process are: have a national quality management system standard or a quality management system required by national regulation, apply a risk management process complying with ISO 14971, and assign to each software system a software safety class (A, B, or C).
The development team is required to formulate a software development plan (or multiple plans) to govern the execution of activities within the software development process. This plan must align with the extent, complexity, and software safety classifications of the software system under development. The software development life cycle model must either be comprehensively outlined within the plan (or plans) or appropriately referenced.
For each software system of the medical device, the development team shall define and document software system requirements from the system level requirements. Afterwards they need to transform the requirements for the medical device software into a documented architecture that describes the software’s structure and identifies the software items.
They need to iteratively enhance the software architecture until it is broken down into distinct software units. Subsequently, they must proceed to create and document a comprehensive design for each individual software unit within the software item.
Software system testing is just as important. Development teams are required to define and execute a series of tests. These tests should include input stimuli, expected outcomes, pass/fail criteria, and associated procedures. Their purpose is to facilitate the testing of the software system in a manner that ensures all software requirements are thoroughly assessed and validated.
IEC 62304 software maintenance process
Given that a significant number of field-related incidents involve service or maintenance of medical device systems, which can include improper software updates and upgrades, it's essential to recognize that the software maintenance process holds equal significance to the software development process. In fact, the software maintenance process closely parallels the software development process.
The development team is required to create a software maintenance plan (or plans) that will guide the activities and tasks within the maintenance process. This plan should encompass the following aspects:
- procedures for:
-receiving
-documenting,
-evaluating
-resolving and
-tracking - criteria for determining whether feedback is considered to be a problem.
- use of the software risk management process;
- use of the software problem resolution process for analyzing and resolving problems arising after release of the medical device software;
- use of the software configuration management process to manage modifications to the existing system; and
- procedures to evaluate and implement:
-upgrades
-bug fixes
-patches and
-obsolescence
IEC 62304 in our work
Incorporating IEC 62304 into our development practices as a software development company is a crucial step to ensure the safety, effectiveness, and quality of medical device software.
As noted above it’s important for us to create a comprehensive software development plan that outlines the software development lifecycle, including milestones, activities, and deliverables. This plan aligns with the scope and safety classification of the software system. We identify and manage potential risks associated with the software throughout its lifecycle. Risk management is an integral part of our development and maintenance processes.
We carefully document and analyze software requirements, ensuring that they are complete, unambiguous, and traceable. Requirements traceability is crucial for demonstrating compliance. We follow a systematic approach to software architecture and design, refining the architecture until it is broken down into software units. Each unit is designed, documented, and reviewed thoroughly.
We maintain meticulous documentation throughout the development process, including design documents, risk management records, and testing documentation. This documentation ensures transparency and traceability. We work closely with regulatory experts to ensure that the software complies with applicable regulatory requirements, including FDA's 510(k) or premarket approval processes.
As we’ve seen throughout this post the importance of robust standards cannot be overstated. IEC 62304 standard, one of the medical device software standards, serves in guiding the development, maintenance, and deployment of software within medical devices. Which is increasingly important as technology continues to advance and medical devices become increasingly intertwined with software.