Usability Planning & Strategy
Planning the usability activities wisely is one of the most important phases in your path to clearance.
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.
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.
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.
More usability services for medical devices
Use-Related Risk Analysis
Rely on our expertise to bring the user perspective into your risk assessment. Identify and minimize the use-related risks to ensure compliance with the latest FDA/MDR Human Factors guidelines.
Design for medical devices
Design a safe and innovative user experience for your medical product. Introduce risk mitigations by design and ensure compliance with the latest design guidelines for medical devices.
Usability testing
Evaluate the usability of your product throughout the development cycle. Use our expertise to plan and moderate test sessions, analyze the results and a generate a thorough report, in compliance with human factors guidelines and regulations.
Recruitment & testing facilities
Let us take care of all the required logistics, from participant recruitment to testing facilities, for seamless worldwide usability studies.