The FDA emphasises human factors engineering as an important tool in improving the safety of medical devices. This is mirrored by the EU's Medical Device Directives, which now include requirements for device manufacturers to establish and follow a Usability Engineering Process. To help businesses meet these guidelines, as well as make healthcare products as safe and user-friendly as possible, you might need us at Auxergo.
Auxergo is a solutions-driven human factors and usability engineering consultancy in the healthcare industry providing effective, high-quality and reliable human factors solutions for medical devices or systems. We deliver a range of human factors techniques for formative studies, risk management, and summative evaluations (validation), and can manage all aspects of a usability project, whether it is participant recruitment or the final report for regulatory submission.
Based in Cambridge in the UK and Shanghai in China, we work internationally with all sizes of companies in the healthcare industry. Our team of specialists with different backgrounds are from the University of Cambridge. We provide a complete project management service and all projects are carried out to conform with the highest industry standards and guidelines.
We tailor a comprehensive project strategy and project plan to support your workflow. After that, we help you to improve your medical devices and systems. Our company has a comprehensive understanding of FDA 2016 human factors and medical device guidelines; IEC 62366; MHRA 2021 Human Factors and Usability Engineering; AAMI/ANSI HE-75:2009/(R)2013; UCM 259760; ISO 14971; ISO 13485; EU 2017/745; EU 2017/746; and NMPA regulations 2018 to meet regulatory requirements.
Auxergo has offices in Cambridge in the UK and Shanghai in China, click here for our contact information.
Cambridge is the centre of the "Silicon Fen" region, and we are at St John's Innovation Park, Cambridge cluster, which hosts a number of knowledge-based companies with high growth potential.
We are at the Pudong New Area which is the premier destination in Shanghai for talent and companies, and home to the Shanghai free trade zone and a host of world-class business parks.
OUR CORE PRINCIPLES
Transparency and honesty are important to us. We believe it is vital to building and maintaining commercial relationships.
We make sure that all the work we do is rigorous and professional, which is integral to the delivery of high quality work.
In all aspect of our work we are driven to excel. It is a fundamental part of our culture and ethos, and feeds in everything we do.
MEET OUR EXECUTIVE TEAM
Managing Director and
Penelope cares deeply about how to improve patient safety and medical devices using human factors.
Penelope has post graduate degrees in human factors engineering from the University of Cambridge and more than 5 years’ technical and commercial experience leading projects on a range of drug delivery devices, clinical medical devices, surgical equipment, wearables, apps, and telehealthcare products. She has a deep understanding of human factors research methods, the safety critical aspects of device interaction, and the validation of end-user devices.
Chief Scientific Advisor (CSA)
Robyn has a PhD in biophysics from the University of Cambridge and an MPhys from the University of Manchester with a year abroad at the University of California, Berkeley. Following his PhD, he was a post-doctoral researcher at the University of Cambridge, looking at applications of physics to medicine.
He is now a consultant for the life sciences, as well as scientific advisor to Auxergo, working to bring the next generation of medical devices to reality. Robyn has over 10 published papers in respected scientific journals, including Nature Communications and Soft Matter, and a published patent on VACS (vortex actuated cell sorting).
Chief Data Architect
Kevin Zhou graduated with a PhD in Computer Science from the University of Cambridge, as a Benefactor Scholar of St John’s College. Currently he is working as a post-doctoral researcher at the University of Cambridge in the Computer Lab. His main research area is massively parallel and distributed computing for accelerating deep learning algorithms.
He has been involved in several projects on building machine learning related systems and is highly experienced in building-ultra scale data collection, learning and prediction frameworks.
MEMBERSHIPS AND ACCREDITATION
Auxergo is proud to be a member of several respected human factors and healthcare organisations in both the UK and China:
Auxergo focuses on human factors and usability engineering, and as such works alongside the best industry has to offer in other fields in both the British and Chinese healthcare industries. We are able to support all fields of medical device or system design and development with the help of our partners.