REF. E-MDR-F-09 – E-LEARNING
EUROPEAN REGULATIONS
REGULATION (EU) 2017/745
COURSE DESCRIPTION
The Production/Purchasing package is composed of 5 modules and has been designed specifically to present, in an interactive format, the main obligations of the Production and Purchasing Departments to ensure compliance with Regulation (EU) 2017/745.
DURATION
150 minutes, including 95 minutes of lessons and 55 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 the Production/Purchasing Departments
PREREQUISITES
Familiarity with the MD sector
ACCESS
The CEISO ACADEMY platform can be accessed for a period of four 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 Production/Purchasing Departments’ activities
COURSE CONTENT
- Overview of Regulation (EU) 2017/745
- EUDAMED & UDI
- General Safety and Performance Requirements
- Technical Documentation
- 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 5 modules (final quiz/success criteria >= 80%). When trainees pass the final quiz, they receive their training certificate, as well as the corrected quiz, by email.
