Ketryx provides configurable tools that can be aligned with the requirements of ISO 13485, IEC 62304, and ISO 14971, and we can provide documentation mapping the standards to Ketryx features. Many of our customers are happy to hear that we are actually certified to ISO 13485, IEC 62304, and ISO 14971 by UL Solutions, the oldest certifying body in the world. As a result, we can provide our customers with a validation package, including a requirements traceability matrix, to our customers upon request. We can work together to ensure your workflows and items in Ketryx correspond to the key elements of these standards, helping you maintain compliance and streamline your processes. If needed, we can collaborate to create custom documentation specific to your organization’s use of Ketryx in the context of these standards.

Additionally, any documentation such as work instructions, manuals, and reference guides can always be found at docs.ketryx.com.