IEC 62366-1:2015+A1:2020 specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This course provides a detailed presentation across 12 topics listed below and includes key check points and questions to ask as the design progresses towards the design transfer stage. A 60 Question Quiz to help practice and reinforce key concepts covered in the session.
This course includes extensive hands-on study of the standard using application examples to reinforce learning. Depending on the duration a complete case study may be used to enable participants to get firsthand experience of how to apply and meet the requirements of the standard. Time permitting some customization, and application to participant’s products may also be discussed.
Who Should Attend
This course is most suitable for Managers and Leaders and all those work with Product development/managing product teams.
Through training, Design and Development staff, Quality/Regulatory professionals, New/Sustaining Product Engineers, and others will learn to apply/practice usability principles in their work setting.
- Terms and Definitions
- What is usability Engineering
- Risk Control via User Interface Design
- Safety and Usability
- Use Specification
- User Interface Characteristics
- Hazards, Failures, Hazardous Situations
- Applying Usability across the Design and Development Phase
- Creating User Interface Specification
- Summative and Formative Evaluations of User Interface
- Risk Control and Residual Risk
- Application Example(s)
16 hours (2 days x 8 hours per day)
8:30am-4:30pm (EST) each day