---
title: "A Playbook for Transforming Jira to Support IEC 62304 Compliance"
type: white-paper
publisher: Ketryx
source: "https://www.ketryx.com/assets/a-playbook-for-transforming-jira-to-support-iec-62304-compliance"
content: text extracted from PDF (layout/tables/figures not preserved)
---

# A Playbook for Transforming Jira to Support IEC 62304 Compliance

*Source: [https://www.ketryx.com/assets/a-playbook-for-transforming-jira-to-support-iec-62304-compliance](https://www.ketryx.com/assets/a-playbook-for-transforming-jira-to-support-iec-62304-compliance)*

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A Playbook for Transforming Jira to Support IEC 62304 Compliance

Introduction As software becomes more integral to medical devices, the need for efficient, agile development tools and processes has grown. However, medical device manufacturers face an increasingly complex challenge in driving development agility while ensuring compliance with stringent standards, such as IEC 62304. A significant disconnect often exists between development teams eager to use modern tools and quality teams focused on using tried and true methods for regulatory compliance. This disconnect can lead to delayed product timelines and slower time to market. But what if there were a way to bridge this gap, empowering developers to use their preferred tools while also meeting regulatory compliance requirements? As the project management tool most widely used by developers worldwide, Jira is uniquely positioned to increase speed and reduce the complexity of medical device software development. But while Jira is an incredibly effective project management tool, it is not validated or compliant by design. Therefore, using Jira in the development of regulated software requires adding third-party plugins and customized features. In many cases, to maintain compliance, teams are forced to document things twice — once in Jira and once in the eQMS or ALM tool. This increased workload can diminish the overall advantages of using a tool like Jira for efficient development. Let’s examine Jira’s benefits for MedTech, plus expert guidance on how to address the challenges of using this tool for regulated compliance. © Ketryx Corporation 2025 2

1. Limitations of legacy tools and processes: Many MedTech companies still rely on outdated development tools and methodologies that are ill- equipped to handle the complexity of contemporary software systems. 2. Regulatory compliance requirements: The need to adhere to strict standards, such as IEC 62304, often conflicts with the agile, iterative approach favored by modern development tools. 3. Risk aversion: The high stakes involved in medical device software development can lead to a conservative development approach that resists adopting new tools and methodologies, even if they offer significant benefits. The gap between modern developer tools and traditional MedTech The increasing complexity of modern software systems has given rise to a diverse ecosystem of developer tools designed to address the unique challenges of web applications, data-driven systems, mobile apps, and large-scale deployments. However, this evolution wasn’t designed for the specific needs of regulated and high-risk software development, particularly in the medical technology sector. As a result, MedTech companies are struggling to keep pace with modern development practices due to several factors: MedTech is still struggling to catch up with software development advancements from the 2000s and 2010s. 4. Change management: The stringent change management requirements imposed by regulatory bodies create an additional layer of complexity. Every software modification must be meticulously documented, assessed for impact, and validated, which can slow the rapid iteration and continuous deployment approaches of contemporary software development. Companies must also continuously monitor their products after release, collecting and analyzing performance data. Any issues identified through this surveillance may necessitate further changes — each requiring the same rigorous documentation and validation process. This ongoing cycle of monitoring, assessment, and controlled modification slows development significantly. 1980s – 1990s Foundation in Safety-Critical Industries • Emphasis on aerospace, defense, automotive, telecommunications. • Early tools like IBM DOORS for requirements management. 2000s – 2010s Agile and Project Management Tools • Rise of Agile methodologies necessitates new tools. • Transition to iterative, dynamic development processes. Early 2010s – Present DevOps and Cloud-Based Applications • Integration of DevOps practices for CI/CD alongside cloud computing growth. • Address the scalability and flexibility needs of internet-scale applications. Mid 2010s – Present Data-Driven Applications & AI • Surge in AI and machine learning development requires DataOps and MLOps. • Focus on handling large datasets and complex computations. © Ketryx Corporation 2025 3

Why MedTech companies need modern development tools and practices Despite these challenges, MedTech companies are increasingly eager to adopt modern development tools and agile methodologies for several reasons. First, agile practices let manufacturers efficiently manage the complexity of their software by breaking development into smaller, manageable increments, which helps teams adapt to changing requirements. By automating routine tasks and streamlining workflows, modern tools and agile methodologies also increase efficiency and reduce the manual work required by older systems. This enables faster, more cost-effective development, resulting in quicker time to market. Better development tools also create opportunities to enhance software capabilities and integrations, leading to more sophisticated, user-friendly, and effective medical technology. This type of innovation is vital in the competitive MedTech landscape, where shortened development cycles can increase product differentiation. Faster releases allow companies to iterate quickly and stay ahead of market demands. Moreover, MedTech companies need to attract and retain the best and brightest developers in order to stay competitive. Top-tier professionals often expect to work with cutting-edge tools in modern development environments. By using contemporary development practices, MedTechs can build appealing workspaces that satisfy these expectations. This will be particularly important as the industry competes with unregulated sectors to attract talent. Companies risk high attrition rates if they fail to provide the modern tools and workflows that developers prefer. The cost of recruiting, hiring, and training new developers to replace those who leave can often amount to double the annual salary of a single developer, making retention a clear cost-cutting priority. O N LY 35% of MedTech projects are developed on time and on budget due to gaps in R&D productivity and execution.* Competitive Advantages of Modern Development Tools Transitioning to modern development tools and practices offers MedTech companies significant business benefits: • Modern software development tools increase developers’ efficiency through automation and streamlined workflows. • Increased efficiency and shorter development cycles enable companies to dramatically decrease time to market for new products and updates. • More agile processes enable companies to stay ahead of the competition, rapidly adapting to changing market demands and regulatory requirements. • Adopting cutting-edge tools and methodologies helps companies attract and retain top developer talent. * McKinsey MedTech Pulse Report — September 2023 © Ketryx Corporation 2025 4

The challenge of adopting modern tools for MedTech development While the benefits of modern development tools are clear, their adoption in the MedTech sector presents challenges due to misalignment between the design principles of these tools and the strict regulatory compliance standards that govern medical device software development. Modern software development solutions like Jira, Git, and CI/CD tools are designed for fast-paced, flexible environments that prioritize rapid iteration. However, their architecture and feature sets are not inherently built to satisfy the rigorous traceability, documentation, and validation requirements mandated by regulations such as IEC 62304. The process of adapting non-compliant development tools for use in a regulated environment can be arduous. To bridge the compliance gap, companies may need to engage in extensive manual work, including creating custom scripts, maintaining separate documentation systems, and manually duplicating information across multiple platforms to ensure traceability. This negates much of the efficiency gained from modern tools and can potentially introduce new risks of human error and inconsistency. Additionally, each customization or workaround must be thoroughly documented and justified, which creates an additional layer of complexity. Under these circumstances, developers may feel frustrated by the red tape and required manual processes, while quality teams struggle to maintain compliance without impeding development speed. Bridging this gap requires a solution that can integrate compliance features into popular development platforms while minimizing manual work and providing the efficiency that underpins these tools’ appeal. © Ketryx Corporation 2025 5

The value of Jira for modern software development Jira has established itself as a leader in project management and issue tracking for software development. It offers centralized issue and task management, simplified project management with customizable workflows, robust support for agile methodologies, and enhanced team collaboration tools. According to one large-scale survey of agile software development practitioners, Jira is the most used agile project management tool with 77% of respondents saying they would recommend using Jira based on their experience. A closer look at the challenges of IEC 62304 For medical software manufacturers, Jira’s customizable workflows and integration options have the potential to support efficient development processes, reduce manual errors, and give a clear overview of project progress. However, although Jira may theoretically offer these benefits, using it to manage IEC 62304-compliant software presents several critical challenges. © Ketryx Corporation 2025 6

IEC 62304 key requirements IEC 62304 mandates a comprehensive approach to medical device software development. It requires rigorous software development lifecycle management. It emphasizes testing and documentation, calling for detailed test plans, cases, and procedures, coupled with meticulous documentation of all aspects of the software development process. Risk management and mitigation play a crucial role in IEC 62304 compliance, with the standard demanding a robust process to identify, analyze, and control risks throughout the software lifecycle. Additionally, IEC 62304 places significant importance on traceability and change control, requiring clear links between software requirements, design specifications, implementation, and test deliverables. These interconnected requirements ensure a systematic, safety-focused approach to medical device software development. © Ketryx Corporation 2025 7

Why Jira alone doesn’t solve for compliance In its standard form, Jira is not inherently designed to ensure compliance with these requirements. Its agile, granular, and item-based nature doesn’t naturally align with the more structured approach often used in traditional 62304 compliance. The difficulties in using Jira alone for IEC 62304 compliance include: • Limited traceability and immutable record-keeping: Jira doesn’t inherently provide the level of traceability required by IEC 62304, nor does it offer immutable records necessary for regulatory audits. • Insufficient risk management features: Standard Jira lacks built-in tools for comprehensive risk assessment and management as required by IEC 62304. • Inadequate testing and QA capabilities: While Jira can track testing tasks, it doesn’t provide the detailed test management and documentation features needed for medical device software. • Lack of comprehensive documentation: Jira’s focus on task management means it’s not designed to generate or manage the extensive documentation required for regulatory compliance. • Misaligned terminology and structure: Jira’s overall design (which includes epics, stories, and sprints) doesn’t map to the regulated software development lifecycle (SDLC) required by IEC 62304. Some customizations can be built for Jira to make it better aligned with regulated development, but they can introduce significant challenges. Creating and maintaining custom Jira configurations requires time and specific expertise. Teams must carefully design and implement specialized workflows, custom fields, and issue types to meet regulatory requirements. These custom configurations can also complicate Jira upgrades and plugin integrations. Furthermore, validating custom configurations for regulatory compliance creates additional work, and must be repeated whenever significant changes are made to the configuration. Are multiple point solutions an efficient workaround? To address the shortcomings of traditional MedTech software development for meeting regulatory compliance, some organizations attempt to adapt their existing SDLC management processes through custom integrations, third-party plugins, or by cobbling together various specialized software tools. However, this approach often introduces a new set of challenges.

The use of separate tools for different aspects of compliance can lead to disjointed data and workflows, resulting in siloed information and fragmented processes. Maintaining clear links between artifacts across multiple systems becomes increasingly complex, making it difficult to achieve the end-to-end traceability required by regulatory standards. Furthermore, each additional tool introduces a new validation requirement, significantly increasing the overall work required to meet compliance standards. Managing multiple tools adds complexity, resulting in increased maintenance time and higher overall costs. Another important consideration is that these plugins do not offer enterprise support — which means that if the plugin breaks, software that uses it cannot be released. Finally, users are faced with a longer onboarding process as they must become proficient in multiple systems. This steeper learning curve can lead to reduced productivity across teams. Therefore, multiple point solutions can often hinder the very processes they were built to optimize. © Ketryx Corporation 2025 8

Transforming Jira into an IEC 62304-compliant tool with Ketryx To bridge the gap between Jira’s capabilities and IEC 62304 requirements, Ketryx offers integration that extends Jira’s functionality to support compliance. Here’s how Ketryx transforms Jira into a powerful tool for IEC 62304-compliant software development: Ketryx creates Part 11-compliant records of all development activities and decisions within Jira, ensuring that closed records cannot be altered and are fully traceable. This also facilitates the generation of complete and accurate audit trails required for regulatory compliance. Instead of having to duplicate requirements to carry them from one version to another, Ketryx allows you to maintain requirements and tracks changes throughout the lifecycle of each requirement. And rather than generating documents that are merely a snapshot of Jira, Ketryx allows you to see each version in Jira independently, improving both traceability and documentation. Immutable Records and Audit Trails “The manufacturer shall create an audit trail whereby each: a) change request; b) relevant problem report; and c) approval of the change request can be traced.” — IEC 62304:2006, 8.2.4 PROBLEM Jira does not allow users to maintain long-lived items like requirements because it doesn’t have a ticket versioning system supported by immutable records and comprehensive audit trails. SOLUTION Implement immutable records and audit trails within Jira. This will immediately identify changes between configuration items, show changes between versions, and transition the completed items from open to closed. Implement robust versioning so you can maintain the requirement throughout its lifecycle. See Part 11-compliant audit trails in Jira with Ketryx © Ketryx Corporation 2025 9

PROBLEM Jira alone lacks the capability to link all these elements comprehensively, hindering traceability. SOLUTION Establish end-to-end traceability within Jira. Easily see gaps in traceability and prevent dangling requirements that are not connected to the appropriate tests or specifications. By linking requirements, design artifacts, code changes, tests, and risks within Jira, Ketryx establishes the end- to-end traceability required by IEC 62304. Users can see what changes were made and when through viewing a full history and audit trail of each item. This enables effective impact analysis and demonstrates compliance with traceability requirements. Ketryx goes beyond Jira with traceability to other systems, allowing you to trace automated tests from Git and vulnerabilities from your cybersecurity tools. Comprehensive Traceability “The [software development] plan shall address […] traceability between system requirements, software requirements, software system test, and risk control measures implemented in software.” — IEC 62304:2006/Amd 1:2015, 5.1.1 “The manufacturer shall document traceability of software hazards as appropriate: a) from the hazardous situation to the software item; b) from the software item to the specific software cause; c) from the software cause to the risk control measure; and d) from the risk control measure to the verification of the risk control measure.” — IEC 62304:2006, 7.3.3 See local traceability in Jira with Ketryx © Ketryx Corporation 2025 10

PROBLEM Jira doesn’t provide documentation, so most organizations use a manual document generation process. This process is time-consuming and prone to errors, affecting consistency and completeness. SOLUTION Automate the creation of compliance documentation, like the SRS, SDS, test reports, V&V reports, and more. This should also include a comprehensive requirements traceability matrix. Automated Document Generation See how Ketryx automates documentation Documentation required by IEC 62304 includes: • Software System Requirements (5.2.1) • Software Architectural Design (5.3.1) • Software Detailed Design (5.4.2) • Tests and Test Reports (5.6.3, 5.6.7) • Anomalies (5.8.2) • Released Versions (5.8.4) • Risk Management Activities (7.1.4–9.2) Ketryx automates the creation of compliance documentation and evidence, such as requirements, specifications, test reports, and risk assessments, based on data captured in Jira. This reduces manual effort and ensures consistency and completeness of compliance documentation. Unlike other systems, Ketryx has robust document templating, which ensures that compliance documentation aligns with regulatory standards. Ketryx’s RTM can accommodate the complexity of large systems of systems, while trace matrix generators are limited by the number of items or levels of depth. Finally, Ketryx creates documentation from systems besides Jira, like Git, your testing tools, and your cybersecurity tools. © Ketryx Corporation 2025 11

PROBLEM Jira does not provide built-in quality management controls that ensure adherence to approved procedures. SOLUTION Integrate quality management controls within Jira. PROBLEM Jira lacks integrated risk management features required for proactive risk identification and mitigation. SOLUTION Integrate risk management features within Jira. Embedded Quality Management Controls Risk Management Integration See how Ketryx enforces your QMS in Jira See how Ketryx integrates risk management within Jira “The manufacturer of medical device software shall demonstrate the ability to provide medical device software that consistently meets customer requirements and applicable regulatory requirements.” — IEC 62304:2006, 4.1, Quality Management System “The manufacturer shall identify software items that could contribute to a hazardous situation identified in the medical device risk analysis activity of ISO 14971…” — IEC 62304:2006, 7.1–7.4.3, Software Risk Management Process Using Jira automation alone adds complexity and additional maintenance. With Ketryx, quality management controls are automatically configured and enforced within Jira, ensuring that development teams adhere to approved procedures. Ketryx incorporates 62304-compliant risk management functionalities into Jira, enabling continuous risk assessment and mitigation throughout the development process. Ketryx also connects to your cybersecurity tools and testing in Git so you can manage risks across your entire SDLC, not just in Jira. Ketryx gives you the ability to reuse risks across projects, so you can see and manage hazards and harms wherever they exist. © Ketryx Corporation 2025 12

PROBLEM Jira does not support Part 11-compliant electronic signatures, making it difficult to maintain compliance. SOLUTION Enable Part 11-compliant signatures directly in Jira. Part 11-Compliant Approvals Process See how Ketryx integrates Part 11-compliant signatures in Jira 21 CFR Part 11, Part 820 and IEC 62304 drive specific requirements for electronic signatures used in software design controls. Ketryx enables Part 11-compliant signatures directly in the Jira interface, enabling seamless approval and review processes without needing to leave Jira. Ketryx also allows you to run reviews on requirements, approve those requirements with a Part 11-compliant signature, and create controlled records that are later displayed in documentation. © Ketryx Corporation 2025 13

Benefits of using Ketryx and Jira together The integration of Ketryx and Jira allows developers to remain in their preferred environment, using familiar tools and workflows. It minimizes disruption and maximizes productivity, eliminating the need for developers to copy and paste their work into separate systems. It also automates many compliance-related tasks and maintains a constant state of audit readiness, which significantly reduces the preparation required for regulatory audits. With Ketryx enhancing Jira’s capabilities, development teams can focus more on developing features and fixing bugs, which translates into faster product iterations and more rapid updates. This proactive approach maintains a high level of quality throughout the development lifecycle while reducing the risk of non-compliance. By bridging the gap between agile development and regulatory requirements, the Jira-Ketryx combination helps medical device software teams accelerate time-to-market without compromising on quality or regulatory standards. © Ketryx Corporation 2025 14

Modernize your IEC 62304-compliant software development While Jira offers powerful capabilities for modern software development, it falls short of meeting the stringent requirements of IEC 62304 on its own. Attempts to bridge the gap with extensive workarounds and/or multiple point solutions often lead to increased complexity and fragmented workflows. Ketryx provides an ideal solution by integrating with Jira to transform it into a platform for IEC 62304-compliant development. As medical device development accelerates, the ability to use modern development tools while maintaining regulatory compliance will be critical for success. With Ketryx, you can efficiently manage the entire product lifecycle by connecting best-of-breed tools to power faster development while ensuring quality and compliance. Watch our hands-on webinar to see live demonstrations of how Ketryx integrates with Jira to support compliant medical device software development. © Ketryx Corporation 2025 15

To learn more about efficiently integrating Jira into your development while maintaining compliance, contact us today at www.ketryx.com Schedule a demo today by scanning this QR code or visiting: https:/ /go.ketryx.com/jira