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Using Jira in Medical Device Development

Transform Jira into IEC 62304 compliance

Make Jira, the most widely used project management platform for software development worldwide, work for you.

Jira was not designed for regulated development. Teams using Jira face issues with:

Maintaining immutable records
and electronic signatures
Enforcing control over Total
Product Life Cycle (TPLC)
Validating the Non-Product
Software (NPS) toolchain
Tracing across
other systems
Visibility into validated Software
Development Lifecycle (SDLC)
Release faster and stay compliant

Transform Jira into a validated, compliant platform for medical device development

Ketryx transforms Jira into a compliant platform for medical device development, no bespoke customizations or expensive consultants needed. 
Compliant in your tools

Let your developers work in the modern tools they love, while Ketryx enables a 62304-compliant process in the background.

Traceability

Traceability across the total product lifecycle

Ketryx ensures seamless traceability, allowing you to track every aspect of your product's lifecycle — from user requirements to specs to tests — while you’re working in Jira.

Track every change with end-to-end traceability across the entire product lifecycle, from initial design to final release.
Easily view dependencies and relationships between requirements, specifications, tasks, risks, and tests through the traceability widget in Jira.
Enforcement

Keep your developers’ work compliant

Ketryx enforces your SOPs in Jira so your developers’ work stays compliant. 

Gate releases and approvals in a way that aligns with your quality processes, i.e. V&V tests won’t run for uncontrolled requirements or unapproved test cases.
Prevent unauthorized or untrained personnel from approving.
Once approved, items are immutable to prevent process deviation.
Preferred DevTools

Part 11-compliant signatures in Jira

Keep your developers in Jira with Part 11-compliant secure and legally binding electronic signatures within Jira.

Electronic signatures meet 21 CFR Part 11 requirements, providing a secure, verifiable way to approve documents and changes.
Be audit-ready by ensuring all electronic records are authenticated, authorized, and tamper-proof.
Documentation

Automated document generation

Automatically transform the work you do in Jira into compliant documentation. Ketryx automates evidence collection and documentation creation directly from Jira, eliminating tedious manual documentation.

Every Jira ticket and change is automatically used to create a Part 11-compliant audit trail.
Automatically generated documents are structured to meet IEC 62304 requirements so that you’re audit-ready.
Ketryx validates Jira to its intended use as a service, providing you documentation of the Jira validation.
Risk Management

Risk management in Jira

Ketryx integrates IEC 62304 and ISO 14971-compliant risk management features into your Jira platform, enabling proactive identification and mitigation of risks.

Track and evaluate risks continuously as they appear and establish traceability, all in Jira.
Identify and manage risks in Jira throughout the development process with risk mitigation integrated into every stage.
Why Ketryx?

Accelerate development across your AI lifecycle with Ketryx.

Book a demo