BERGO
BERGO UK is a leading usability and human factors consultancy specializing in medical devices. Founded in 2009, it has extensive experience in applying usability engineering principles to ensure medical devices are safe, effective, and user-friendly. BERGO offers a range of services including usability evaluations, risk analysis, documentation, user research, training, and specialized courses to help clients achieve regulatory compliance and optimal device design.
Industries
Nr. of Employees
small (1-50)
BERGO
Glencloy, Montrose Terrace, Bridge of Weir, PA11 3DD, United Kingdom
Products
Specialist usability analysis software
Software tools to support structured capture of usability analyses, manage use-related risk analyses and generate documentation for the usability engineering file.
Specialist usability analysis software
Software tools to support structured capture of usability analyses, manage use-related risk analyses and generate documentation for the usability engineering file.
Services
User-centred formative studies and expert inspections using usability testing, heuristic evaluation and cognitive walkthroughs to inform iterative design and generate evidence for design decisions.
End-of-development validation studies to demonstrate device usability by intended users in realistic conditions, including acceptance criteria design and full study execution.
Task analysis and use-related risk analysis to identify use errors and hazardous situations, supported by specialist analysis tools and established guidance, integrated with regulatory risk management.
Develop usability engineering files, human factors reports for regulatory bodies, SOPs, UI specifications and gap analyses required by usability standards and country-specific guidance.
Mixed-methods research projects (interviews, focus groups, contextual enquiry, surveys) to capture user needs, preferences and contextual constraints early in development.
Short courses and bespoke training on implementing usability engineering processes, compliance with IEC 62366 and related guidance, conducting user research and URRA, and preparing UE/HFE deliverables for regulatory submissions.
User-centred formative studies and expert inspections using usability testing, heuristic evaluation and cognitive walkthroughs to inform iterative design and generate evidence for design decisions.
End-of-development validation studies to demonstrate device usability by intended users in realistic conditions, including acceptance criteria design and full study execution.
Task analysis and use-related risk analysis to identify use errors and hazardous situations, supported by specialist analysis tools and established guidance, integrated with regulatory risk management.
Develop usability engineering files, human factors reports for regulatory bodies, SOPs, UI specifications and gap analyses required by usability standards and country-specific guidance.
Mixed-methods research projects (interviews, focus groups, contextual enquiry, surveys) to capture user needs, preferences and contextual constraints early in development.
Short courses and bespoke training on implementing usability engineering processes, compliance with IEC 62366 and related guidance, conducting user research and URRA, and preparing UE/HFE deliverables for regulatory submissions.
Expertise Areas
- Usability and human factors engineering for medical devices
- Formative and summative human factors evaluation
- User research and mixed-methods studies
- Task analysis and use-related risk analysis (URRA)
Key Technologies
- Formative usability testing
- Summative human factors validation testing
- Heuristic evaluation
- Cognitive walkthrough
News & Updates
Formative evaluation of a mobile app for treatment of chronic insomnia disorder. Conducted for Closed Loop Medicine Ltd in June 2023.
Formative evaluation of an implantable pouch to fit pacemakers and neurostimulators. Conducted for Hylomorph in August 2022.
User research study into a system for people with Type 1 diabetes. Conducted for UNEEG Medical in December 2020.
Insight discussing the application of usability/human factors engineering to AI-enabled medical devices and the challenges involved.
Insight providing observations on the FDA’s draft guidance on human factors information in marketing submissions.
Insight discussing the FDA’s recent draft guidance on human factors information in marketing submissions and its implications.
Formative evaluation of a mobile app for treatment of chronic insomnia disorder. Conducted for Closed Loop Medicine Ltd in June 2023.
Formative evaluation of an implantable pouch to fit pacemakers and neurostimulators. Conducted for Hylomorph in August 2022.
User research study into a system for people with Type 1 diabetes. Conducted for UNEEG Medical in December 2020.
Insight discussing the application of usability/human factors engineering to AI-enabled medical devices and the challenges involved.
Insight providing observations on the FDA’s draft guidance on human factors information in marketing submissions.
Insight discussing the FDA’s recent draft guidance on human factors information in marketing submissions and its implications.