Our Expertise
Core services for
medical device usability
Task Analysis
Systematically breaking down the device use process into sequences of tasks.
Identifying Critical Tasks and development of Use Scenarios.
Use-Related Risk Assessments
Evaluating hazards & risks associated with device use in line with ISO 14971, including Known Use Problem (KUP) searches .
Expert reviews
Our extensive experience and product exposure in the field give us the Human Factors expertise to identify use related issues and make recommendations.
Contextual Inquiry/Interviews
Direct observations, data collection and user needs generation in the natural use environment.
We are particularly skilled at carrying out ethnographic research globally to offer unique insights.
Formative Evaluations
Exploring design strengths, weaknesses and unanticipated use errors, through desk-based research and real users.
Complete study planning, execution and reporting,
HF Validation studies
Assessing the design at the end of device development , following guidance from the FDA,AAMI. IEC and MHRA.
Complete study planning, execution and reporting,
Human Factors documentation
All HF documentation created in a clear and concise format for a fully comprehensive Usability Engineering Product File, ready for reference and notified bodies.
Competitor benchmarking
Quantitative and qualitative evaluation of your competitors products.
MDR remediation
Upgrading product legacy files to prove that user interfaces are safe and effective.
Are you looking for a contractor?
Whether you are a Human Factors consultancy that needs extra project bandwidth support to run a study and prepare documentation, or a corporate client in need of an expert contractor, A2HF provides tailored support to your needs.
Contact us to discuss your project’s Human Factors needs
Reach out to A2HF Ltd for bespoke human factors consultancy, usability testing, and regulatory compliance guidance.
Contact A2HF to discuss our services.
Telephone: ++44 7534 937558
E-mail: alexagis@a2hf.com
Address: A2HF Ltd , 7 Barton Manor, 26 Michelgrove Road, Bournemouth, BH51LB