Training

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Training in Medical Device Usability

Dates

6 - 7 November 2012


Venue

Medicoindustrien, Nivaagaard, Gl. Strandvej 16, 2990 Nivå, Denmark. Show on Map


Registration

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Enquiries

Dr Nick Bradley

Tel: +44 (0)781 313 5723

Email: training@bergo.co.uk


Programme

Course Overview

‘Usability (or human factors) engineering’ has become a hot topic in the medical device industry. Essential requirements related to usability have been revised and escalated in Directive 2007/47/EC.

Subsequently, regulatory bodies are placing greater pressure on manufacturers to conform with usability requirements through compliance with ISO/IEC 62366:2007 Application of Usability Engineering to Medical Devices.

Further, to get premarket approval in the United States, manufacturers may need to provide a Human Factors Engineering report and must consider guidance documents such as ANSI/AAMI HE75: 2009, Human Factors Engineering – Design of Medical Devices.


What you will learn

Delegates will learn how to:

  • Achieve compliance with IEC 62366: 2007
  • Use design guidance in ANSI/AAMI HE75: 2009
  • Select and apply usability techniques
  • Develop testable requirements for usability
  • Manage the risk of use-error
  • Develop a usability engineering process
  • Document usability activities in the usability engineering file and HFE report (US)

The course consists of a mixture of lectures, case studies and workshops which can be based on examples brought to the course by the participants.

“This course has a very good balance between the theoretical and practical aspects of Usability Engineering. We brought home motivation, a deeper understanding, and several techniques that can be seamlessly implemented into our design and development projects. Highly recommended for organisations that take product safety and ease of use seriously.”

Irvin Mangwiza, Project Manager, DELTA
Klaus Mayntzhusen, Medical Engineer, DELTA


Who Should Attend

The course is targeted at (but not limited to):

  • Product design engineers
  • Project managers
  • Regulatory managers
  • R&D personnel
  • Risk management staff
  • Quality assurance managers
  • Clinical trial managers

About the Presenter

Nick Bradley

Dr Nick Bradley is the manager and founder of BERGO, a leading usability consultancy with extensive training experience in the medical device industry.

Nick assists, and delivers training for, a range of medical device manufacturers across Europe in all aspects of the usability engineering process and IEC 62366.

He holds a PhD in Human-Computer Interaction (HCI) from Strathclyde University, a BSc in Ergonomics from Loughborough University and a Diploma in Professional Studies (DPS) from the same institution.

Nick has published work in a variety of application areas in healthcare and HCI. He is a Graduate Member of the Institute of Ergonomics and Human Factors (IEHF), a full member of the Human Factors & Ergonomics Society (HFES) and a reviewer for the Journal of Applied Ergonomics.