The Ketryx platform is designed to support and document compliance processes for various standards, including IEC 62366-1. Ketryx allows you to configure workflows, track usability requirements, and document risk assessments related to usability engineering. Documentation such as work instructions, manuals, and reference guides can always be found at docs.ketryx.com.

Since IEC 62366-1 is closely tied to ISO 14971 (Risk Management), we have extensive experience with risk management activities. Our Client Operations team, which includes regulatory professionals that have successfully worked with IEC 62366, can help configure your Ketryx environment to meet both usability and risk management requirements. We can also provide our risk management documentation, developed to support ISO 14971, and tailor it to your specific IEC 62366-1 needs.

Additionally, Ketryx’s advanced templating mechanism (documented here) can streamline the creation of product release documentation related to IEC 62366-1. This feature allows users to automatically generate standardized documents, ensuring that usability engineering activities are consistently tracked and compliant with regulatory requirements.

Our team will work with you during onboarding to set up custom workflows, templates, and documentation, ensuring that usability engineering processes are integrated into your quality management system.