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Your usability roadmap

Whether your product seeks regulatory approval or is already released and in need of a retrospective usability evaluation, planning the usability activities wisely is one of the most important phases in your path to clearance. ​

Cognit's usability specialists will collaborate with your regulatory team to devise a usability strategy that makes the best out of the given resources, while ensuring that your project aligns with usability best practices and regulatory expectations.

The usability plan functions as a roadmap for addressing usability concerns throughout the project, facilitating effective scheduling and resource allocation for usability activities in each phase of product development.

The gap analysis helps identify the necessary usability activities and deliverables for your product. We will review existing documentation and previous usability activities to ensure there are no deviations from regulatory requirements, and that potential gaps are addressed early on.
UOUP (Usability of Unknown Provenance - IEC:62366-1.2015) is a less known path to MDR clearance. Its objective is to assess whether use related risk is reduced to acceptable levels, for devices commercialized prior to the standard's release date for which usability documentation is not available. Based on the product use specification, review of post market surveillance data and hazards related to usability, we will identify and assess existing risk control measures and establish whether user interface modifications are required to reduce risk, or risks are reduced to an acceptable level from the usability standpoint.

We perform the evaluation in compliance with IEC 62366-1 (2015), prepare the required documentation and provide support for any need or question that might arise along the process.