1. Define software safety classes:
Properly categorize the software into safety classes based on its potential impact on patient safety and intended use. This classification informs subsequent development activities.
2. Establish a software development plan:
Develop a comprehensive plan outlining the software development process, including roles, responsibilities, and milestones, to ensure a systematic approach.
3. Identify software requirements:
Clearly define and document the software requirements, encompassing functional, performance, and safety requirements, to guide the development process effectively.
4. Create a software architecture:
Design a robust software architecture that aligns with the defined requirements and safety classes, outlining the software's structure and interactions.
5. Implement and verify software:
Write code that complies with the established architecture and requirements. Perform rigorous testing to verify that the code functions as intended.
6. Conduct software integration and testing:
Integrate individual software components and thoroughly test their interactions, detecting and addressing any issues early in the process.
7. Perform software system testing:
Assess the overall system's functionality and performance, ensuring that the software operates as expected within the medical device.
8. Prepare and maintain software documentation:
Maintain detailed documentation throughout the development process, including design documents, test plans, and reports, to facilitate traceability and compliance.
9. Manage software configuration:
Implement a robust configuration management process to track changes and ensure the integrity of the software throughout its life cycle.
10. Address risk management in software development:
Continuously identify and assess risks associated with the software, implementing risk controls and mitigation strategies to enhance patient safety.
