BS EN 62366 Usability Engineering for Medical Devices
DURATION
1 dayCPD
Equivalent to 8 hoursCERTIFICATES
All delegates will receive a certificate on completion.DELIVERY OPTIONS
The 1-day usability engineering workshop explores the usability engineering methodology detailed in BS EN 62366, from analysing and specifying the design, through identifying potential risks, to verifying and validating the user interface. The tutor will use a combination of teaching, interactive workshops and group discussions around the development of a real product to explore the application of usability engineering.
Delegates will learn how to expand their current risk management activities to ensuring the user interface of their medical devices is safe and effective, in line with the expectations of the EU and FDA in the US.
- R&D managers/engineers
- RA/QA managers/engineers
- management representatives
- members of multi-discipline design teams
- members of design review teams
- ergonomic designers
- usability engineers
- product, project, and programme managers
- Internal auditors
The course complements Bywater’s range of courses applicable to the medical device industry.
- expectations of the FDA and the EU in applying usability analysis to medical devices
- applying the usability management standard BS EN 62366 to medical devices
- the relationship between ISO 14971 and the EU directive and the implications the changes represent
- usability and use errors and examples of risks associated with user interfaces
- the stages of the Usability Engineering Process
- application of usability analysis methodologies, such as FMEA, to medical devices
- principles of usability management planning in developing procedures and practices to analyse, evaluate and control usability
- sources of information and further development
- apply the Usability Engineering Process in BS EN 62366 to medical devices and to conduct usability analysis to identify hazards and possible use errors
- understand how to prepare the documents for the key stages of the Usability Engineering Process: application specification, primary operating functions, characteristics relating to safety, hazard identification, usability specification, usability validation plan
A certificate of completion will be awarded to delegates who attend and fully participate in the course, which recognises their new understanding of the Usability Engineering Process.
Course Delivery
This course is available on a dedicated basis. Please contact our team on 0333 123 9001 to discuss scheduling training on your preferred date at your premises, a venue of your choice or within our virtual classroom.
As well as delivering tutorials to explain the principles of usability engineering, our expert and experienced tutors run 5 workshops across the duration of the course to enable delegates to practise applying their new knowledge to the development of a real product.
We encourage group discussion and collaboration, as well as welcoming questions to the tutor to help attendees leave the course ready to apply their learning in their work environment. As one attendee later commented: ‘It has changed the way I will work. 5 out of 5 for course tutor – very approachable, lots of useful experiences.’
Bywater runs a wide range of complementary training courses around requirements for placing medical devices in markets around the world. These include:
- Introduction to ISO 13485:2016 for Medical Devices
- ISO 13485:2016 Internal Auditor Course
- ISO 14971 Risk Analysis for Medical Devices
- Risk Analysis and FMEA for Medical Devices
We also offer training courses on standards for medical laboratories:
- Introduction to ISO 15189 for Medical Laboratories
- ISO 15189 Internal Auditor
This is the process for a manufacturer to analyse, specify, design and evaluate usability, as it relates to safety of a medical device. The usability engineering process is specifically developed to reduce everyday errors, lower risks and ensure general equipment safety. Human Factors and Usability Engineering in medical device design is also required by the FDA’s Quality System Regulation (QSR).
Customer reviews
West Midlands Police|11th Apr, 2024
Xiros Ltd|5th Apr, 2024
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East Lancashire Hospitals Nhs Trust|8th Feb, 2024