BS EN 62366 Usability Engineering for Medical Devices

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.

This course provides valuable information for those involved in the design and development of medical devices, including:

• 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.

Key topics covered on this course include:

• 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

Live tutor-led learning combines with practical application in a course structure similar to:

• WELCOME AND INTRODUCTION
• Module 1 Background and Changes to the new Medical Device Regulation
• Module 2 Description of the EN 62366 Standard
• Module 3 FDA Requirements
• Module 4 Use specification
• Module 5 Workshop 1: Using a real product – Defining the use specification
• Module 6 User Interface Characteristics
• Module 7 Workshop 2: Using a real product – Identify User Interface Characteristics
• Module 8 Identify known or foreseeable hazards and hazardous situations
• Module 9 Workshop 3: Using a real product – Identify known or foreseeable hazards and hazardous situations
• Module 10 User Interface Specification
• Module 11 Workshop 4: Using a real product – User Interface Specification
• Module 12 Establish User Interface Evaluation Plan
• Module 13 Workshop 5: Using a real product – Evaluation Planning
• Module 14 Perform User Interface design implementation and formative evaluation
• Module 15 Summative Evaluation
• Module 16 User Interface of Unknown Origin
• Summary and Course Evaluation
• CLOSE