Course description
The Usability Engineering for Medical Devices (EN 62366) One-Day Course is designed to provide participants with a comprehensive understanding of usability engineering principles and requirements as specified in EN 62366:2007+A1:2014. This course focuses on applying human factors engineering to ensure the usability, safety, and effectiveness of medical devices throughout their lifecycle. Participants will learn how to conduct usability assessments, mitigate risks associated with use errors, and enhance product usability in compliance with regulatory standards.
Upcoming start dates
Suitability - Who should attend?
Who Should Attend:
- Usability engineers, human factors specialists, and product designers involved in medical device development.
- Quality assurance professionals and regulatory affairs specialists responsible for ensuring compliance with usability standards.
- Engineers, project managers, and stakeholders seeking to enhance product safety and usability through human factors engineering.
Outcome / Qualification etc.
Certification:
Participants will receive a certificate of completion upon fulfilling the course requirements, demonstrating their understanding of usability engineering principles and EN 62366:2007+A1:2014 requirements.
Training Course Content
Morning Session:
- Introduction to Usability Engineering: Principles, benefits, and regulatory framework.
- Overview of EN 62366:2007+A1:2014: Requirements and application in medical device usability.
- Human factors and usability considerations in medical device design and development.
- Risk management and risk assessment methodologies specific to use errors.
Afternoon Session:
- Usability evaluation methods: Conducting heuristic evaluations and usability testing.
- Mitigating use-related hazards and enhancing user interface design.
- Case studies and practical exercises: Applying EN 62366 principles to real-world scenarios.
- Documentation requirements: Developing usability engineering files and usability test reports.
- Q&A session and knowledge assessment: Reviewing key concepts and preparing for practical implementation.
Course Objectives:
- Understand the principles and importance of usability engineering in the design and development of medical devices.
- Gain proficiency in interpreting and applying the requirements of EN 62366:2007+A1:2014.
- Learn techniques for conducting usability evaluations and usability testing.
- Identify and mitigate risks associated with use errors and human factors issues.
- Develop skills in integrating human factors into the design and development processes of medical devices.
- Understand the documentation and reporting requirements for usability engineering in regulatory submissions.
Benefits:
- Enhance knowledge and skills in usability engineering specific to medical devices.
- Ensure compliance with regulatory requirements and standards for product safety and effectiveness.
- Improve product design and development processes through effective usability assessments and testing.
- Network with industry peers and experts to exchange insights and best practices in usability engineering.
Course delivery details
Course Format:
- Duration: One day (8 hours)
- Delivery: Instructor-led training, available in both in-person and virtual formats.
- Interactive Learning: Practical workshops, case studies, and group discussions to reinforce learning.
- Comprehensive Materials: Participants will receive course handouts, templates, and a certificate of completion.
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