# IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies Jan Pöschko November 13, 2023 ## Table of Contents - [Old RTM Management & IEC 62304 Traceability](#old-rtm-management-and-iec-62304-traceability) - [Is Jira natively compliant with IEC 62304?](#is-jira-natively-compliant-with-iec-62304) - [Benefits of 62304 Traceability in Jira](#benefits-of-62304-traceability-in-jira) - [Requirements Traceability Matrix (RTM) Reports in Jira](#requirements-traceability-matrix-rtm-reports-in-jira) - [How to Generate 62304-compliant Requirements Traceability Matrix (RTM) Reports from Jira](#how-to-generate-62304-compliant-requirements-traceability-matrix-rtm-reports-from-jira) IEC 62304 defines the software development lifecycle (SDLC) processes for medical device software. With traceability as a main component of this standard, the challenge companies often face is how to use preferred development tools like Jira for SDLC management that are not built to provide the level of traceability required by 62304 and the FDA. This guide will focus on how companies can meet IEC 62304 and generate a compliant [Requirements Traceability Matrix (RTM)](/content/blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm/index.html) while using Jira. ## Old RTM Management & IEC 62304 Traceability Most companies using Jira (or similar project management tools) approach building their RTM by manually copying and pasting information into [spreadsheets](/content/blog/the-best-rtm-tools-for-agile-teams-looking-beyond-excel/index.html), an error-prone method that often leads to version control issues. Unfortunately, the growing complexity of software exacerbates the flaws in older RTM management methods like these. ## Is Jira natively compliant with IEC 62304? No. Jira doesn’t offer a native mechanism for generating the type of evidence required by the FDA, especially when it comes to generating the RTM. Jira’s compliance with specific standards depends on how it is configured, used, and integrated within your organization's processes. This means that the complexity and costs of maintaining 62304 compliance are squarely on the manufacturer. Typical modifications include customization of workflows and fields, process definitions, user training, documentation, audit, validation, and verification are just a few requirements teams must address. As a special note on validation, we strongly recommend against validating your own development tools, which are expensive, time-consuming, and provide no competitive edge. Former Amgen Quality Assurance Specialist Jake Stowe details the challenges in validating your own development tools [here](/content/blog/the-turtle-problem/index.html). Compliance with standards like IEC 62304 involves both tool usage and the establishment of appropriate processes and practices within your organization. While Jira can be a valuable tool in this process, it is not a one-size-fits-all solution. ## Benefits of 62304 Traceability in Jira Jira has become the industry standard in software project management, being used in over 125,000 companies worldwide. Therefore, the #1 benefit is that developers and product managers alike know the platform well. **1. Traceability**: If augmented, Jira can provide a clear, structured, and compliant way to link requirements, design specifications, test cases, and other crucial artifacts. **2. Streamlined Collaboration**: IEC 62304 compliance involves many teams, including software developers, quality assurance, and regulatory affairs professionals. Jira allows for real-time communication, task assignment, and progress tracking. These capabilities are useful for medical device teams handling complex software. However, these benefits do not matter unless your team’s processes are compliant with 62304, and your team is actively transferring data into an RTM. And the truth is, most teams fail to do this reliably. ## Requirements Traceability Matrix (RTM) Reports in Jira A good Requirements Traceability Matrix (RTM) report serves as a powerful tool for tracking and ensuring that every requirement in a project is appropriately fulfilled and tested. Its components include: 1. **Requirement Identifier & Description**: Each requirement is uniquely identified. 2. **Source**: The origin of the requirement, such as a specific customer request, regulatory standard, or internal design specification. 3. **Type of Requirement**: This could include functional requirements and non-functional requirements. 4. **Status**: Current status of the requirement. 5. **Owner/Responsible Party**: The person or team responsible for fulfilling the requirement. 6. **Change History**: A log of changes made to the requirement over time. 7. **Comments/Notes**: Space for comments and additional information. 8. **Verification and Validation Results**: Documentation of the results of the verification and validation activities. 9. **Traceability Links**: Cross-references to show how each requirement relates to other project artifacts. Teams need platforms like Jira to remain agile, but many of those benefits are negated by the huge amounts of manual labor required for documentation. ## How to Generate 62304-compliant Requirements Traceability Matrix (RTM) Reports from Jira Ketryx offers a streamlined process for creating RTM reports directly from Jira with [native integration](/content/capabilities/jira-connector/index.html). Here's how it works: 1. Ketryx configures 11 pre-built issue types in Jira. 2. Developers continue their work within Jira, utilizing their preferred environment. 3. Ketryx simplifies the process of linking issue types within each Jira ticket. 4. Behind the scenes, Ketryx constructs a fully functional and FDA-compliant traceability matrix. 5. Ketryx automatically documents every action, maintaining a Part 11-compliant audit trail and version history. 6. This automation ensures that every issue is meticulously documented and traceable, enhancing efficiency and compliance. 7. Ketryx automatically validates Jira to this intended use and provides those design control documents directly to customers.