IEC 62304

IEC 62304 is an international standard that defines a lifecycle framework for developing and maintaining medical device software. It establishes a structured, risk-based approach that aligns software activities with patient safety and regulatory expectations.

The standard applies to both embedded software (Software in a Medical Device, SiMD) and standalone software (Software as a Medical Device, SaMD). Rather than prescribing specific development methods, IEC 62304 defines the processes and documentation needed to demonstrate that medical device software is developed, verified, and maintained in a controlled, traceable way.

Key points:

• Establishes a risk-based lifecycle covering development, maintenance, configuration management, and problem resolution 
• Defines safety classes (A, B, C) based on potential patient harm, determining the required level of development and verification rigor
• Requires end-to-end traceability across requirements, architecture, implementation, testing, and risk controls 
• Focuses on processes, not methods, and is widely accepted by FDA and EU MDR regulators

Structure and Requirements of IEC 62304

IEC 62304 is structured around a set of defined lifecycle processes that outline the activities required to develop and maintain medical device software in a controlled and compliant manner. For each activity, the standard specifies required outputs and documentation throughout the development process (chapter 5), including:

• Software development planning (5.1)
• Software requirements analysis (5.2)
• Software architectural design (5.3)
• Software detailed design (5.4)
• Software unit implementation and verification (5.5)
• Software integration and integration testing (5.6)
• Software system testing (5.7)
• Software release (5.8)

Rather than prescribing specific tools or development models, IEC 62304 focuses on ensuring software is developed systematically, with clear evidence that requirements are correctly implemented and verified. In addition, the standard defines supporting processes that apply across the software lifecycle, including maintenance, risk management integration, configuration management, and problem resolution. Together, these processes ensure changes, defects, and post-market updates are handled in a traceable and controlled way.

The standard also emphasizes process discipline, documentation, and traceability, enabling manufacturers to align software development with quality and regulatory frameworks such as ISO 13485, ISO 14971, FDA 21 CFR 820, and EU MDR.

Software Safety Classification in IEC 62304

IEC 62304 introduces a software safety classification scheme to align development rigor with potential patient harm caused by software failures. Classification is based on the worst-case hazardous situation that could result from a software malfunction, after considering external risk-control measures.

The assigned class determines the required level of development, verification, documentation, and review. Higher-risk software receives proportionally greater scrutiny, while lower-risk software can be developed more efficiently within the same compliant framework.

IEC 62304 software safety classes:

• Class A: No injury or damage to health possible
• Class B: Non-serious injury possible
• Class C: Death or serious injury possible

Implementing IEC 62304 in Software Development

MATLAB^® and Simulink^® provide an integrated environment that supports IEC 62304 process and documentation requirements across the medical device software lifecycle for both standalone (SaMD) and embedded (SiMD) applications. Together, they support systematic software development, enabling teams to define requirements, implement functionality, and perform verification in a consistent, controlled workflow.

Within an IEC 62304–aligned workflow, teams use MATLAB and Simulink to support traceability, verification, maintenance, and change control. You can verify software behavior through simulation and testing, with results documented and linked to requirements. As software evolves, you can analyze and re-verify changes using the same environment, supporting controlled software maintenance and problem resolution.

When used within a quality management system, these workflows support the documentation needed for FDA and EU MDR audits. MATLAB and Simulink are also TÜV SÜV certified for IEC 62304–compliant development workflows.

Future of IEC 62304

A second edition of IEC 62304 is expected to address the increasing complexity of medical device software and the evolution of development practices while maintaining its core focus on patient safety and process discipline. Proposed updates aim to better align with related standards such as ISO 13485, ISO 14971, and IEC 82304; clarify lifecycle expectations; and support modern development approaches, including iterative and agile workflows.

The future revision is also expected to clarify requirements around software maintenance, cybersecurity, and the increasing use of software across connected and data‑driven medical devices. Until the second edition is formally released, regulators and manufacturers continue to rely on the current edition while monitoring proposed changes to ensure future readiness and ongoing compliance.