Rebus Medical
Human factors consultancy focused on applying usability and human factors engineering to medical devices, combination products and medicinal products. Services include integration of HF into design and regulatory strategy, formative and validation usability studies, use-related risk analysis, development of user-facing instructional materials, and HF documentation to support regulatory submissions. The organisation also provides training, templates and resources and reports holding ISO 13485:2016 certification for its quality management system.
Industries
Nr. of Employees
small (1-50)
Rebus Medical
Bristol, Bristol, City of, United Kingdom, Europe
Products
Human Factors Handbook (downloadable resource)
A published handbook resource covering human factors principles, methods and applied guidance for medical device development (available as a free download).
FDA HFE summary report template
A template intended to structure human factors summary reporting suitable for FDA submissions.
Conference posters and downloadable HF resources
Posters and downloadable resources covering topics such as HF integration with clinical investigations and Agile formative frameworks presented at HFES HCS events.
Human Factors Handbook (downloadable resource)
A published handbook resource covering human factors principles, methods and applied guidance for medical device development (available as a free download).
FDA HFE summary report template
A template intended to structure human factors summary reporting suitable for FDA submissions.
Conference posters and downloadable HF resources
Posters and downloadable resources covering topics such as HF integration with clinical investigations and Agile formative frameworks presented at HFES HCS events.
Services
Regulatory-aligned HF strategy and integration into device development lifecycles, mapping HF activities to standards and organisational processes.
Design and delivery of formative usability studies using representative end users and observational methods to inform design iterations.
Protocol design, execution and reporting of HF validation studies to provide evidence for FDA and European certification submissions.
Applying ISO 14971-aligned processes and techniques (task mapping, uFMEA, URRA, HAZOP, Fault Tree Analysis) to identify and mitigate use-related hazards.
Design and review of IFUs, quick guides, labelling and training materials aligned with HF principles and the device design.
Bespoke training courses and workshops to build internal HF capability and awareness across design, risk and project teams.
Regulatory-aligned HF strategy and integration into device development lifecycles, mapping HF activities to standards and organisational processes.
Design and delivery of formative usability studies using representative end users and observational methods to inform design iterations.
Protocol design, execution and reporting of HF validation studies to provide evidence for FDA and European certification submissions.
Applying ISO 14971-aligned processes and techniques (task mapping, uFMEA, URRA, HAZOP, Fault Tree Analysis) to identify and mitigate use-related hazards.
Design and review of IFUs, quick guides, labelling and training materials aligned with HF principles and the device design.
Bespoke training courses and workshops to build internal HF capability and awareness across design, risk and project teams.
Expertise Areas
- Human factors and usability engineering for medical devices
- Formative and summative usability testing
- Use-related risk analysis (URRA, uFMEA)
- Human factors documentation for regulatory submissions
Key Technologies
- Usability testing (formative and summative)
- Cognitive walkthroughs
- Contextual inquiry
- Use-related FMEA (uFMEA)
News & Updates
Presentation of posters on coordinating human factors studies with clinical trials and developing an Agile formative framework at HFES Healthcare Symposium 2024 in Chicago.
Attendance and poster presentation ('Is HF required for drug products') at HFES HCS 2023 and dissemination of key conference insights.
Poster and resource describing approaches to integrate HF activities with clinical investigations to reduce risks to subjects and support device development.
Explanation of the value of an ISO 13485-aligned QMS for HF service providers and how it supports consistent, risk-based service delivery.
Guidance for selecting HF vendors including QMS, sector experience, risk management, data analysis and outsourcing considerations.
Discussion of when independent ethical review (IRB) is required for HF studies in different jurisdictions and recommended best practices.
Presentation of posters on coordinating human factors studies with clinical trials and developing an Agile formative framework at HFES Healthcare Symposium 2024 in Chicago.
Attendance and poster presentation ('Is HF required for drug products') at HFES HCS 2023 and dissemination of key conference insights.
Poster and resource describing approaches to integrate HF activities with clinical investigations to reduce risks to subjects and support device development.
Explanation of the value of an ISO 13485-aligned QMS for HF service providers and how it supports consistent, risk-based service delivery.
Guidance for selecting HF vendors including QMS, sector experience, risk management, data analysis and outsourcing considerations.
Discussion of when independent ethical review (IRB) is required for HF studies in different jurisdictions and recommended best practices.