Only Ketryx provides the risk-based approach and real-time visibility required to effectively manage the cybersecurity and ongoing changes inherent to the Cloud across varying hardware, software, and cloud-based systems.

The FDA PCCP (Predetermined Change Control Plan) allows MedTechs to make changes without having to resubmit every time yet, MedTechs still struggle with the required reporting. Ketryx automatically outputs the required documentation including a detailed product architecture, software configurations, ML models, datasets and change management directly from modern dev tools, such as Jira and Github -- saving time, money and accelerating innovation.

Supports updates to software application and infrastructure in controlled, documented manner

Allows for monthly, weekly, and even daily releases

Automatically compiles change histories from modern developer tools

Working with Ketryx gives you access to a team of world-class developers, quality and regulatory professionals (former FDA talent) as well as experts in AI and Cloud. The Ketryx built-in intelligence draws upon this collective experience to automate and eliminate repetitive tasks within Ketryx so you can focus on the work that excites you.