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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 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.


Keep your developers’ work compliant

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

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.


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.

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.