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Innovative technology and design consultancy Cambridge Design Partnership today announced that due to the huge success of Europe’s first AAMI Human Factors for Medical Devices course they will be sponsoring more courses in 2015.

Cambridge Design Partnership worked with the US based Association for the Advancement of Medical Instrumentation (AAMI) and Pure Insight to bring the course to Europe for the first time in April 2014 and the course was hugely oversubscribed. In response to demand from medical device development companies, which deem the course content as a ‘must have’ piece of knowledge for their medical device development teams, a course has been scheduled for January 2015. 

Cambridge Design Partnership have recognised the importance of Usability Engineering in medical device development programmes for many years and are keen to share this enthusiasm with the wider development community by teaming up with AAMI and Pure Insight to bring this definitive course to Europe.

This course delivers practical Usability Engineering techniques that can be implemented in any medical device development programme and gives insights into creating usability submissions for both the USA and the EU regulatory regimes.  With new guidelines proposed in the US, medical device companies worldwide need to be vigilant in understanding how to navigate these changing regulatory landscapes. The AAMI course not only addresses Usability Engineering itself, it also looks at the growing harmonisation between global standards, streamlining device submissions.

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. This course is exclusively the only event held in Europe where companies can talk directly to an FDA representative who hosts a question and answer session and gives delegates the benefit of the latest insight into streamlining submissions as well as common submission errors and deficiencies.

“At CDP our experience developing novel medical devices shows us that effective Usability Engineering is crucial to commercial success, not only to meet regulatory requirements but to enable new products to succeed in a competitive marketplace. When developing fast moving consumer products companies naturally place the user at the centre of the design process,  but when it comes to safety critical medical devices sometimes the complex technical and clinical requirements overshadow basic patient needs. This course explains the processes you can use to ensure your devices are easy and safe for patients to use.  Medical device manufacturing companies must demonstrate this to the regulators and this course explains how this is achieved.” Comments Mike Cane, Founder, Cambridge Design Partnership.

The course will be held on the 27th- 29th January 2015 at Park Inn Conference Centre, Heathrow Airport, UK.  To find out more about the course content watch this short video from the course lecturers- https://vimeo.com/108803287
 

You can register for the course online at: www.medical-device-regulations.com

Follow the course on Twitter @AAMI_TrainingEU.

-ends-

Cambridge Design Partnership is a leading technology and product design partner focused on helping its client's businesses grow. Some of the world’s largest companies trust CDP to develop their most important innovations.

Cambridge Design Partnership specialises in the healthcare, consumer, energy and industrial equipment markets and its multidisciplinary staff have the expert knowledge to identify opportunities and solve the challenges its clients face.

www.cambridge-design.co.uk/
hello@cambridge-design.co.uk

Contact Abbie Meliniotis or Laura Cavaliere at CDP for more information:
lc1@cambridge-design.co.uk / avm@cambridge-design.co.uk /+44 (0) 1223 264428

Media contacts: Andrea Berghäll, EML Wildfire Technology PR
cdp@emlwildfire.com / +44 (0) 208 408 8000

About Pure Insight

Pure Insight are a leading competence development agency that helps industry practitioners to manage innovation more effectively. They deliver a range of tailored services to a global customer base who seek to improve their internal processes, or make innovation easier for people to use.
www.pure-insight.com

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