CPDEquivalent to 8 hours
CERTIFICATESAll delegates will receive a certificate on completion.
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
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).
We offer our BS EN 62366 Usability Engineering for Medical Devices training course on a dedicated basis. That means we can deliver the training in accordance with your preferences – online in our live Virtual Classroom, or at a convenient venue for face-to-face training, and at a date to suit you.
Metropolitan Police Service|16th Nov, 2023
Sense Biodetection Ltd|13th Nov, 2023
Premier Partnership|10th Nov, 2023
Sense Biodetection Ltd|8th Nov, 2023
Animal and Plant Health Agency (APHA)|7th Nov, 2023
Animal and Plant Health Agency (APHA)|27th Oct, 2023
Orthoplastics Ltd|27th Oct, 2023
The Royal Mint|25th Oct, 2023
Private|24th Oct, 2023
DSTL|17th Oct, 2023
Swann-Morton Ltd|13th Oct, 2023
Mars|10th Oct, 2023