Auxergo

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 consultancy in the healthcare industry providing effective, high-quality and reliable human factors solutions for healthcare devices or systems. We deliver a range of human factors techniques for formative studies and summative evaluations (validation), and can manage all aspects of a 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 can provide a complete project management service and all projects are carried out to conform to 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.

Company’s Keywords:

human factors, medical devices, healthcare system, user research, usability testing, quality management system, drug delivery devices, validation study, regulatory support, risk management, human factors studies, usability studies & solutions