E-MDR-MOD-06 – Conformity Assessment

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 regarding market authorization, as well as classification and UDI rules (N.B. covered in the Overview, EUDAMED and UDI, Market Authorization and MD Classification 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

• Understand the conformity assessment procedures for medical devices according to Regulation (EU) 2017/745
• Understand the Technical Documentation’s sampling principles in the framework of Medical Device conformity assessments

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.