Rebus Medical puts human factors (HF) at the heart of the medical device design process. We deliver strategic regulatory compliance inline with key standards, including ANSI / AAMI / IEC 62366-1, ISO 14971, ISO 13485 and FDA, and MHRA HFE Guidance, while effortlessly dovetailing with existing organisational procedures, systems and structures.
Rebus Medical exists to improve the lives of patients, healthcare professionals and caregivers around the World. We are a trusted human factors consultancy helping our clients develop safe and effective medical devices.
OUR SERVICES
Identify use-related risks, gain insight into user needs and prepare for product validation with our formative evaluations and user studies. Our experienced team can apply a variety of HF techniques, including usability studies, expert reviews, cognitive walk-throughs and contextual inquiries This builds client confidence in design decisions and reduces both use-related and commercial risks.
Scientific rigour, protocol design, data integrity, precision planning and robust documentation are the foundation of our HF studies. We plan, execute, and report HF validation studies (summative testing) as part of our client’s FDA submission and European certification across a range of devices. All our study documentation follows guidance from FDA, AAMI, IEC, MHRA and industry best practice.
Establishing and maintaining traceability between risk management and HF activities is critical to identifying and controlling use-related risks. We have significant experience in applying ISO 14971 compliant risk management processes, such as HAZOP, URRA, and Fault Tree Analysis, throughout all stages of medical device development. We map user tasks to hazards and risks to help identify and validate appropriate mitigations.
We can support with identifying and defining Hazards, Severities and Hazardous Situations, Known Use Problem Analysis (KUP), Use-Related Failure Modes and Effects Analysis (uFMEA), Risk Assessment updates, and Residual Risk Evaluation workshops.
Developing instructional materials following HF principles ensures that instructions for use, quick reference guides, graphical user interfaces, labelling and training are highly usable and cohesive with the device design. Working closely with device development and risk management teams, we make sure all materials provide quality guidance to the user and support safe and effective device use.
Creating clear and comprehensive HF documents from the start of any development process is vital to get a medical product to market. Health authorities and notified bodies need to quickly understand the reasoning behind key design decisions. We create all levels of documentation, from use specifications and usability engineering plans through to validation reporting and human factors summary reports.