iso 62304 is a standard for medical device software that provides guidelines for the software development process, including software design, development, testing, and maintenance. The standard provides a framework for managing the software development process to ensure that medical device software is safe, reliable, and effective.
The standard applies to software used in medical devices, including standalone software and software that is part of a medical device system. The standard provides guidance for the development of software in accordance with the risk management principles outlined in ISO 14971.
The ISO 62304 standard specifies the software development process through five main stages:
- Planning: This stage involves defining the software development process, including project management, risk management, and software configuration management.
- requirements analysis: This stage involves analyzing and defining the requirements for the software.
- Design: This stage involves developing the software architecture and design based on the requirements defined in the previous stage.
- Implementation: This stage involves coding, testing, and integrating the software components.
- Verification: This stage involves testing the software to ensure that it meets the requirements and is safe and effective for use in a medical device.
The standard also provides guidance on documentation requirements, software maintenance, and software configuration management.
ISO 62304 is an important standard for medical device manufacturers, as it provides a framework for managing the software development process and ensuring that medical device software is safe, reliable, and effective. compliance with the standard is often required by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for the approval of medical devices that incorporate software.