IEC 62304 is a standard in the medical device industry that pertains to the software lifecycle processes of medical device software. Here are some key points about it:

1. Scope: IEC 62304 applies to the development and maintenance of medical device software, regardless of the type of software or the medical device’s classification.
2. Software Lifecycle Processes: The standard outlines processes for the entire software lifecycle, including development, maintenance, risk management, configuration management, and problem resolution.
3. Risk Management: It emphasizes the importance of risk management throughout the software development process. This includes identifying and mitigating risks associated with the software’s use in medical devices.
4. Software Development Lifecycle (SDLC): IEC 62304 outlines processes for software development that align with the software development lifecycle. This includes requirements analysis, architectural design, implementation, verification, validation, and maintenance.
5. Documentation Requirements: The standard specifies documentation requirements for each phase of the software lifecycle. This documentation is crucial for demonstrating compliance with regulatory requirements.

6. The latest version of the standard, IEC 62304  indeed only defines two classes for medical device software: Class A and Class B.

   Here’s the breakdown:

   • Class A: No injury or damage to health is possible, even with failure of the software.
   • Class B: Injury is possible, but it wouldn’t be serious.

   Class C, which referred to software that could cause death or serious injury, has been removed from the standard. The rationale behind this change is that any software that could potentially cause such severe harm would likely be considered a higher-risk device overall, requiring a more rigorous risk management process beyond the scope of IEC 62304.

Product that can help you meet the standard requirements and improve the quality of your software: