Overview
IEC 62304 is an international standard defining the software lifecycle processes for medical device software. It provides guidance to ensure that software in medical devices is safe, reliable, and compliant with regulatory requirements.
The standard is widely adopted by medical device manufacturers and aligns with regulations such as FDA 21 CFR Part 11 and the European Medical Device Regulation (MDR). IEC 62304 applies to all software that is part of a medical device or that controls one.
Key Objectives of IEC 62304
Software Lifecycle Management – Covers the entire software lifecycle, including planning, development, verification, and maintenance.
Risk Management Integration – Aligns with ISO 14971 for identifying and mitigating software-related risks.
Software Safety Classification – Classifies software according to the potential impact on patient safety (Class A, B, or C).
Verification & Validation – Ensures software meets requirements and intended use.
Regulatory Compliance – Supports adherence to international medical device regulations.
Core Elements of the Standard
| Process Area | Description |
|---|---|
| Software Development | Requirements, architecture, design, coding, integration, and testing. |
| Software Maintenance | Process for updating, fixing, and enhancing medical device software. |
| Software Risk Management | Identify hazards, evaluate risks, and implement mitigations according to ISO 14971. |
| Software Configuration Management | Version control, change tracking, and documentation management. |
| Software Problem Resolution | Reporting, analyzing, and resolving software anomalies or failures. |
Importance for the Medical Device Industry
IEC 62304 is critical for ensuring patient safety and regulatory compliance in medical device software. By following this standard, manufacturers can:
Reduce risks associated with software failures.
Demonstrate compliance with international regulatory bodies.
Ensure robust and maintainable software throughout the device lifecycle.
Improve trust and reliability of medical devices in clinical settings.
ITEC and Partner Support
At ITEC, we work with medical device manufacturers and suppliers to implement IEC 62304-compliant software development and risk management processes. From software lifecycle planning and development to verification, testing, and documentation, our partners provide the tools and expertise needed for regulatory compliance and patient safety.
