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Creating and managing the lifecycle of a medical application is expensive, time-consuming, and error-prone. But what if it didn't need to be?
Only Ketryx supports cloud-based AI/ML tools with a single overlay unifying quality and developer functions.
Create regulated applications 2-3X faster.
Get started building software in minutes, not months.
Teams are free to use their preferred tools
Built-in guardrails ensure speed doesn’t compromise safety
Industry expertise includes AI/ML, regulatory, and former FDA talent
MedTechs deploy tools designed for specific teams and their functions -- ranging from quality systems to DevOps frameworks -- to product lifecycle management systems and cloud-based developer tools such as Jira and GitHub.
Tools are siloed and perform different functions, forcing teams to cut/paste data back and forth for compliance purposes. Manually offloading data to enormous tracking spreadsheets leads to human error as well as time and resources spent on hand-offs and rework.
Manufacturers maintain significant amounts of information in the Cloud which further complicates the validation process. Continuously learning AI systems that adapt to real-time data further challenge regulatory assessment and oversight.
Ketryx overlays – but does not replace existing tools to connect and trace all tasks, activities and processes throughout the product lifecycle from design to post-launch.
Ketryx records data directly from the systems used to build the product and automatically submits this information to the FDA for traceability and compliance purposes. As a result, all team members can still use the tools in which they are comfortable during the development process while remaining compliant, eliminating the hours spent on hand-offs and approvals.
When you create an item in Ketryx, there is already a set of defined other items that items can be traced to – ensuring the process is intuitive and logical. With intelligent guardrails, Ketryx doesn’t allow any project to progress unless it is validated and guides users on next steps to stay compliant and move the project forward.
Ketryx ensures that any software developer can become a regulated developer with minimal training. Developers can focus on coding and product impact rather than endless documentation and repetitive hand-offs that
© 2023 Ketryx Corporation
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