Trusted Human Factors expertise
for bringing safe, effective, user-centred medical devices to the market
Supporting product development teams at all project stages - from front end user derived formative research to summative testing for regulatory compliance.
Medical device usability specialists
A2HF Ltd delivers expert human factors consulting for medical devices in line with relevant standards including the FDA Guidance, MHRA HFE Guidance, ANSI/AAMI/IEC 62366-1, ISO 13485 and ISO 14971.
Contract services are available for short or longer term projects.
14+
Years Experience
More than fourteen years of human factors and usability experience in medical device development.
85+
Formative and Validation studies carried out
Conducted over eighty five projects evaluating drug delivery, diagnostic, surgical, and wound care devices with focus on safety and usability.
Comprehensive Human Factors Engineering services
Providing tailored human factors consulting with proven methodologies to enhance device usability, safety, and compliance.
Testimonials
'' I know Alex since September 2023 when he started working with CSL Behring as a Human Factors Consultant. During the years that Alex worked with CSL Behring, he was actively involved in several drug delivery projects... He brought a wealth of previous HF experience and provided a very high standard of Human Factors work... He has worked very closely with other team members and consistently demonstrated professionalism and particular attention to detail. In addition to his technical skills, Alex has very eloquent communication and shows creativity and maturity, making him a really valued presence with us. The team and I have found Alex to be a pleasure to work with. Alex is an assett and I would have no hesitation in recommending him .. ''
Monica Tavanti- Associate Director CSL, Design Assurance - Human Factors
'' Alex worked as a moderator for one of our usability studies that we conducted on a variety of user cohorts from a specific territory where we intended to target a product. From the moment I was introduced to Alex both remotely and then F2F, it was abundantly clear that he is knowledgable, competent and asks all the pertient questions to help maximise my company's investment in the project... Alex is a very talented human factors expert and his interpersonal and intrapersonal awareness is very evident during user study sessions. I thoroughly enjoyed working with Alex and I also enjoyed learning from him on the topic of behavioural science...It was a pleasure to work with you...''
Will Denny - Senior Project Leader, Drug/Device Combination Products at Sandoz GmbH
''We worked with Alex on a summative usability study in October and November 2020. In those times, setting up an in-person study in a safe manner while still getting high quality data was not an easy task but Alex made sure the process went smoothly. The study was setup in a short time and Alex was very flexible when we experienced new challenges such as a difficult test setup or recruitment of 60 participants. We were always able to observe and discuss the data captured throughout the testing, which made the difference, now that we were not able to be there in person. I can therefore recommend Alex for the professionalism and flexibility, especially in those quite challenging times.''
Katrine Peterson - Senior Manager, User Research and Human Factors Engineering
Enhance your medical device safety with expert Human Factors consulting
Contact A2HF Ltd today to learn how our human factors expertise can enhance your medical device development, ensuring usability, safety, and regulatory readiness.
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