Description

The Software Development Plan Template, as outlined in IEC 62304, provides a structured framework for managing the development of medical device software. This template serves as a comprehensive guide for documenting the activities, resources, and schedules involved in the software development process. It includes sections covering software requirements, architecture, design, implementation, verification, validation, and maintenance. By utilizing the Software Development Plan Template, developers can ensure that all aspects of the software development lifecycle are systematically planned, executed, and controlled to meet regulatory requirements and achieve product quality objectives. Compliance with IEC 62304 and adherence to the Software Development Plan Template help to mitigate risks, enhance software reliability, and ultimately contribute to the safety and effectiveness of medical device software.