Training in Medical Device Usability
Enquiries
Contact: Dr Nick Bradley
Tel: +44 (0)781 313 5723
Email: training@bergo.co.uk
Tailored Courses
This course can be tailor-made for all sectors of the medical device industry including drug delivery, diagnostic, respiratory, surgical, orthopaedic, rehabilitation and advanced laboratory instruments.
Programme
Open Enrolment Courses
Medical Device Usability
Glasgow, UK
22-23 February 2012
Medical Device Usability
Intertek, Sweden
8-9 March 2012
View all courses
Course Overview
‘Usability (or human factors) engineering’ has become a hot topic in the medical device industry. This has been due to increasing regulatory pressures placed on manufacturers following the publication of ISO/IEC 62366:2007 Medical Devices - Application of Usability Engineering to Medical Devices.
Further, to get premarket approval in the United States, manufacturers must also consider 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
The course consists of a mixture of lectures, videos and workshops which can be based on examples and cases 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
- Risk managers
- Quality assurance managers
About the Presenter
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) and a full member of the Human Factors & Ergonomics Society (HFES).