Based in Cambridge in the UK and Shanghai in China, we work internationally with all sizes of company, from start-ups to multinationals. Our talented, knowledgeable and experienced human factors specialists, researchers and designers have supported and worked with a large range of healthcare companies. These vary from pharmaceutical and medical device companies (including clinical use and home use medical devices, in vitro diagnostic devices, monitoring devices, drug delivery devices or combination products) to software technology companies (including telehealthcare devices or software systems, hospital systems, and digital devices). We also work with hospitals, care homes and recovery centres.
Regardless of size and type, our clients always return to us repeatedly because we deliver their projects on time and within budget. Our clients consistently comment that they are happy with the work produced, delivering an excellent standard and typically offering critical insights.
Used In Studies
Documentation And Regulatory Reviews
All the projects we work on, and the data we collect and analyse, are kept to global industry level data protection standards and we always guarantee total confidentiality. Data will be stored securely and any published information will be kept anonymous. Projects will not pose any risk to the participant’s safety. Participants will be reminded to only disclose information that they are happy to have published in studies or research. There will be no deception or incentives to take part. In addition, we always ensure our projects are carried out in accordance with the Declaration of Helsinki and are able to be reviewed by Research Ethics Committee in the UK.
Our work also complies with the relevant standards and regulations, and we closely follow the latest guidelines. Namely, these are the FDA human factors and medical device guidelines; IEC 62366-1 usability in medical devices; IEC 62366-2 application of usability engineering to medical devices; AAMI/ANSI HE-75:2009/(R)2013 human factors engineering- design of medical devices; UCM 259760 applying human factors and usability engineering to medical devices; ISO 14971 risk management; ISO 13485 quality management system; EU 2017/745 medical devices directive; EU 2017/746 in vitro diagnostic medical devices; and CFDA regulations 2018.
Our support is available throughout the whole design and development process. We offer tailor-made solutions to meet your business needs. We can provide a complete project management service from patient and healthcare professional recruitment to final report, with one project manager overseeing every aspect of your project.
We have helped many clients test and bring their products to market, often assisting with regulatory approval in the UK and abroad. Here is a current sample of devices we have contributed to, covering areas ranging from in vitro diagnostics, monitoring, connected drug delivery, telehealthcare, hospital systems to digital.
You can find the full details of the services we offer here: EXPERTISE.
Here are a few of our recent testimonials from our clients.
“The Auxergo team are very hard working, efficient and effective. They are a pleasure to work with. They are working on a very high level complex programme which is not easy, and they manage the external and internal relationships very effectively. Their work is always delivered to an excellent standard and they go that extra mile for the company". - CEO, Medical Device Company, UK
“Auxergo was very knowledgeable and professional on human factors and usability engineering. They were passionate, competent and efficient. We value their high-quality work and the comprehensive report they produced”. - Director of Research and Development, Pharmaceutical company, UK
“Thank you for the impeccable report, Auxergo. It really is most outstanding and insightful". - CEO, Digital Medical Device Company, UK
“Auxergo used qualitative and quantitative methods to improve the safety and usability interaction profile of products designed for vulnerable groups of people, including those with chronic diseases and other long term conditions. They demonstrated very good communication skills even within hard to reach groups such as adults with learning disabilities". - Academic, University of Cambridge, UK
“I found that Penelope worked quickly and she had a keen intellect, strong analytical skills and a strong work ethic. I think she has a very good grasp of a number of research methods and has been able to apply them in her work. She also has a great personality and I see no reason that she would not integrate with any well-functioning team”. - Academic, University of Cambridge, UK
“Penelope is a sharp-shooter, sharp, and very tuned in". - CEO, Pharmaceutical Company, UK