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 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; AAMI/ANSI HE-75:2009/(R)2013; UCM 259760; ISO 14971; ISO 13485; EU 2017/745; EU 2017/746; and CFDA 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.
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.