Regulations and reporting hold you back

Tedious compliance reporting
Tedious compliance reporting
Recertifying for ISO and FDA regulations can be a nightmare without a test management tool that helps you ensure requirements are met and compliance documentation is ready. Without a proper way to track historical data, your results are inaccurate.
Lack of risk-management processes
Lack of risk-management processes
All medical device manufacturers need to have established risk management processes that comply with ISO and FDA regulations. Risks must have traceable design artefacts like requirements and design specification that can easily tracked and updated.
Complex software and hardware development
Complex software and hardware development
The process of developing medical devices includes both hardware and software with many requirements that depend on each other. Development teams need visibility into each other’s work, especially the progress of testing to ensure requirements are met.

Release safe and certified products with ease using Xray

Conquer layers of regulations with 1-click reporting

FDA and ISO require full historical data of all testing. With Xray, you have full visibility into all testing activity to ensure data isn’t tempered. Generate end-to-end traceability reports with 1-click using the Document Generator feature from Xray and easily recertify for all regulations.


Establish risk management processes

Xray helps you establish a risk management process that complies with FDA and ISO regulations, with traceable design artefacts like requirements and design specifications that you can easily track and update.


Easily manage complex testing lifecycle

Xray gives your entire development team visibility into coverage and testing. Xray uses Jira native issue types like test cases and test runs that help you ensure full requirements coverage without the need to train on yet another tool.