REF. E-MDR-MOD-08 – E-LEARNING
EUROPEAN REGULATIONS
REGULATION (EU) 2017/745
COURSE DESCRIPTION
The Technical Documentation module presents the content of the Technical Documentation and the information in the documentation regarding post-market surveillance.
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, and more particularly the General Safety and Performance Requirements (N.B. covered in the Overview and GSPR 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
- Familiarity with the Regulation’s Annexes that set out the content of the Technical Documentation (TD)
- Familiarity with the requirements in terms of the TD content for the EU conformity declaration
- Familiarity with the documentation’s elements on post-market surveillance
COURSE CONTENT
Assistance with navigation/Module objectives/Presentation of the course content
- Prerequisites for the conformity declaration (Annex II)
- Post-market surveillance (Appendix III)
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.
