Cambridge Design Partnership founder Mike Cane.
UK-based technology and design consultancy Cambridge Design Partnership has announced that it has arranged with the Association for the Advancement of Medical Instrumentation (AAMI) to bring its highly acclaimed Human Factors for Medical Devices course to Europe for the first time. The course delivers practical usability engineering techniques that can be implemented in any medical device development programme. Importantly, it gives insights into creating usability submissions for both the USA and the EU regulatory regimes.
The AAMI course not only addresses usability engineering itself, it also looks at the growing harmonisation between global standards and streamlining device submissions. With new guidelines about to be enforced in the USA, medical device companies worldwide need to be vigilant in understanding how to navigate these changing regulatory landscapes. If device development teams are not adequately trained in human factors processes and standards, safety critical use errors may be uncovered during validation, resulting in costly and untimely programme delays.
The course, which will be held on April 1-3, 2014, at Heathrow Airport in London, UK, is aimed at anyone involved in bringing medical devices to the market. Well established in the US, ‘Human Factors for Medical Devices’ has always been considered as essential training for integrating human factors into the product development process, with many European companies travelling across the pond to attend.
The course leaders are Dr Ed Israelski, who is the convener of international human factor (HF) medical standards with IEC and ISO and Dr Robert North, who is a co-author of the FDA human factors standards. The course will be the only event in Europe where companies can talk directly with an FDA representative.
“Minimising the possibility of user error through usability engineering and good design practice is a critical part of developing safe and effective new products,” explains Mike Cane, founder, Cambridge Design Partnership (pictured). “We wanted to help make this course available to our healthcare clients and the wider medical device manufacturing community in Europe because we believe it is the best available.”