REF. E-MDR-MOD-11 – E-LEARNING
EUROPEAN REGULATIONS
REGULATION (EU) 2017/745
COURSE DESCRIPTION
The Quality Management System module presents the manufacturer’s obligations regarding the Quality Management System and how it is assessed.
DURATION
23 minutes, including a 15-minute lesson and 8 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
Familiarity with the Regulation’s main definitions and general principles, more particularly market authorization procedures, conformity assessments and post-market surveillance (N.B. covered in the Overview, Market Authorization, Conformity Assessment and Post-Market Surveillance and Vigilance modules)
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 manufacturer’s obligations regarding the quality management system
- Understand how this QMS is assessed by a notified body
COURSE CONTENT
Assistance with navigation/Module objectives/Presentation of the course content
- Requirements applicable to the Quality Management System
- Quality Management System evaluation
- Quality Management System evaluation request
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.
