The AAMI course not only addresses usability engineering itself, it also looks at the growing harmonisation between global standards, streamlining device submissions. With new guidelines about to be enforced in the US, 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 run in April 2014, 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 based companies travelling to the US to attend.
The course leaders are the highly regarded Dr. Ed Israelski who is the convener of international HF medical standards with IEC and ISO and Dr. Robert North, who is a co-author of the FDA human factors standards. In addition, this course is exclusively the only event held in Europe where companies can talk directly with an FDA representative and benefit from their latest insight into streamlining submissions as well as common submission errors and deficiencies.
Understanding the importance of usability engineering in the medical device development process, Cambridge Design Partnership liaised with AAMI and innovation process improvement specialist Pure Insight, which were both keen to make this human factors course, content and speakers available to practitioners working in Europe.
“Minimising the possibility of user error through usability engineering and good design practice is a critical part of developing safe and effective new products,” explained Mike Cane, Founder, Cambridge Design Partnership. “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.”
Cambridge Design Partnership’s team of human factors specialists currently help clients develop successful new products by uncovering the insights and unmet needs that drive the front end of innovation as well as ensure that new products are designed to be enjoyable, inclusive, safe to use and meet regulatory requirements.
The course will be held on 1–3 April at Park Inn Conference Centre, Heathrow Airport, UK. Cambridge Design Partnership is working with Pure Insight, a leading provider of innovation resources and information to development teams, to co-host the course. To find out more about the course and register online, visit www.medical-device-regulations.com.
Cambridge Design Partnership LLP, +44 1223 264428, firstname.lastname@example.org,