REF. E-MDR-MOD-07 – E-LEARNING
EUROPEAN REGULATIONS
REGULATION (EU) 2017/745
COURSE DESCRIPTION
The General Safety and Performance Requirements (GSPR) module presents the safety and performance, design and manufacturing requirements and the information that must be provided with a Medical Device (MD).
DURATION
37 minutes, including a 25-minute lesson and 12 minutes of quizzes
E-LEARNING
TECHNICAL PREREQUISITES
Computer and internet connection
METHODS USED
The module is composed of a lesson in the form of an interactive video with voice-off and learning activities. The module can be accessed 24/7. Reminders are sent to monitor knowledge acquisition and avoid a break in the learning curve.
TARGET TRAINEES
All individuals involved in the MD sector
PREREQUISITES
Knowledge of the Regulation’s main definitions and general principles (N.B. covered in the Overview module)
ACCESS
The CEISO ACADEMY platform can be accessed for a period of two months within two business days at most of approval of your order.
ADDITIONAL BENEFITS
Summary presentation of the regulation
Support materials designed by experienced consultants-trainers
Interactive lesson
Short modules that can be accessed as often as required and autonomously
As an option, you may select Q&A sessions with one of our consultants-trainers
EDUCATIONAL GOALS
- Become familiar with the safety and performance requirements set out in Annex I of the Regulation
- Differentiate the general requirements from those regarding performance, design and manufacturing
- Be aware of the information to be provided with an MD
COURSE CONTENT
Assistance with navigation/Module objectives/Presentation of the course content
- General requirements
- Performance, design and manufacturing requirements
- Requirements relative to information provided with the device
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on each individual’s acquisition of knowledge via a quiz at the end of the program (success criteria >= 80%). If trainees pass the quiz, they receive their training certificate, as well as the corrected quiz, by email.
