REF. E-MDR-F-05 – E-LEARNING
EUROPEAN REGULATIONS
REGULATION (EU) 2017/745
COURSE DESCRIPTION
The REGULATORY AFFAIRS package is composed of 11 modules and has been designed specifically to present, in an interactive format, the main Regulatory Affairs obligations to ensure compliance with Regulation (EU) 2017/745.
DURATION
310 minutes, including 200 minutes of lessons and 110 minutes of quizzes
E-LEARNING
TECHNICAL PREREQUISITES
Computer and internet connection
METHODS USED
The modules are composed of lessons in the form of interactive videos with voice-off and learning activities. They 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, and more particularly MD Regulatory Affairs Departments
PREREQUISITES
Familiarity with the MD sector
ACCESS
The CEISO ACADEMY platform can be accessed for a period of six 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
- Understand the regulatory framework for medical devices
- Identify the requirements that apply and their impact on the Regulatory Affairs Department
COURSE CONTENT
- Overview of Regulation (EU) 2017/745
- Obligations of economic operators
- EUDAMED & UDI
- Market authorization
- Classification of Medical Devices
- Conformity assessment
- General Safety and Performance Requirements
- Technical Documentation
- Clinical evaluation
- Post-Market Surveillance & Vigilance
- Quality Management System
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This package is assessed based on each individual’s acquisition of knowledge via a quiz at the end of each module (practice quiz) and one at the end of the 11 modules (final quiz/success criteria >= 80%). If trainees pass the final quiz, they receive their training certificate, as well as the corrected quiz, by email.
