REF. GR05 – INTRA / INTER
MANAGING RISKS
COURSE DESCRIPTION
At the end of the course, participants will better understand the requirements regarding implementation of the “usability” process and be able to comply with these requirements appropriately.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Update knowledge on the usability engineering process: EN 62366-1 requirements
- Raise the participants’ awareness of the role they play in this process
TARGET TRAINEES
Medical Device (MD) manufacturers, and more particularly:
- R&D team
- Production
- Quality Manager
- Regulatory Affairs Manager
PREREQUISITES
- Familiarity with the MD sector
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Standard document examples
- Regulatory references
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Presentation of the course objectives and method to ensure that they are achieved.
- Regulatory requirements for the implementation of a Usability Engineering Process
- EN 62366-1, its objectives, and the tie to the ISO 14971 risk analysis
- Key definitions
- The specific case of the User Interface of Unknown Provenance
- User specifications
- User interface
- Known or foreseeable dangerous phenomena and situations
- User scenarios related to dangerous phenomena and the validation thereof (summative evaluation)
- Draw up specifications for the User interface
- Draw up the evaluation plan for the User interface
- Design and check the User interface
- Validate the User interface
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).
