Bringing the user's perspective into risk analysis

Regardless of your product's target market, task analysis and subsequent use-related risk analysis (URRA) form the fundamental building blocks for any usability evaluation. They are crucial to help you identify, understand, and minimize the potential risks associated with the use of your product and to ensure compliance with the latest FDA/MDR Human Factors guidelines.

Our human factors team is well versed in bringing the user perspective into your risk assessment. Employing the most current methodologies and drawing from our experience across various medical systems, we will ensure a thorough and comprehensive identification of use errors and recommend the most effective risk control measures to enhance product safety.

More usability services for medical devices

Planning & Strategy

Plan your usability activities early and devise a smart usability strategy which complies with regulatory requirements, while considering your resources and constraints.

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.

Let's talk