The development of medical software requires strict adherence to standards to ensure patient safety and meet regulatory requirements. The IEC 62304 standard defines comprehensive requirements for medical software lifecycle management, from design through maintenance. Healthcare technology product development requires a deep understanding of these requirements so that the development process proceeds safely and efficiently.
Why is the IEC 62304 standard critical for medical software safety?
The IEC 62304 standard forms the foundation for safe medical software development. The standard ensures that software development follows a systematic approach where patient safety is central to every development phase. Compliance with the standard is not merely a regulatory requirement, but also serves as a quality assurance tool that minimizes errors and improves the reliability of the final product.
The standard divides medical software into three safety classes based on their potential for harm. Class A causes no injury or health hazards, Class B may cause non-serious injury, and Class C may lead to death or serious injury. This classification determines the level of requirements for the development process and the depth of documentation. Higher-risk software requires a stricter process and more comprehensive documentation.
Key requirements of the IEC 62304 standard in software lifecycle management
The development process according to the standard begins with the planning phase, where software requirements, architecture, and safety class are defined. During the planning phase, it is critical to integrate risk management in accordance with the ISO 14971 standard. Risk analysis identifies potential hazards and determines their mitigation measures early in the development phase.
During the implementation phase, the standard requires a systematic approach to software architecture design, detailed design, and implementation. Each phase requires appropriate documentation and traceability between requirements and implementation. The testing phase includes unit, integration, and system testing, which must be comprehensive and documented. Compliance with the IEC 62304 standard is not merely a regulatory requirement, but serves as a quality assurance tool that improves software safety and reliability throughout the entire lifecycle.
How Clinipower’s expertise supports meeting IEC 62304 requirements
We have strong practical experience in supporting healthcare technology product development and implementing the IEC 62304 standard. Our team understands the standard’s requirements deeply and knows how to apply them in practical development projects. We provide comprehensive support in software lifecycle management from planning through maintenance.
Our services include integrating risk management into the development process in accordance with the ISO 14971 standard, which is a central part of meeting IEC 62304 requirements. We also assist in developing quality systems and meeting regulatory requirements, including MDR and IVDR regulation requirements. Our international network enables the acquisition of specialized expertise for your organization’s needs.
Usability design and testing are an essential part of developing safe medical software. We provide both formative evaluation during the development phase and summative usability testing, which is mandatory safety testing for medical devices. Our experience from over one hundred usability tests ensures high-quality and standards-compliant implementation.
