- ECOMUNDO x AFNOR -
Bring your Medical Devices into compliance
with European Regulation 2017/745
WHEN?
📅 Tuesday 16th March 2021
🕚03:00 PM - 03:45 AM (CET - Time zone Paris/Europe)
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REGULATION 2017/745
The European Medical Devices Regulation (MDR) 2017/745 came into force in May 2017 in order to answer the increasing demand for safety and efficiency.
The new regulation will apply this year, on 26th May 2021. A deadline that is fast approaching.
This regulation includes several important changes, so we will present you with the main information to help you comply in the best conditions and within the shortest possible time.
In this Webinar, in collaboration with AFNOR, we will focus on the main requirements of the new Medical Device Regulation 2017/745, the deadlines and the steps of compliance.
Furthermore, the involvement of the Notified Body is an important step in the process. It is therefore useful to understand its role and the details of its involvement in the new regulation.
AGENDA
- Presentation of the new regulation 2017/745, the main steps and deadlines,
- Presentation of the requirements and the process of a Medical Device compliance.
- Presentation of the Notified Body role and its importance in the compliance process,
- Presentation of the steps to obtain the certification 13485 and the associated deadlines.
REGISTER NOW!
Raïssa ABDEL-KADER
Medical Device Business Manager
After 6 years of experience as a sales representative with a good knowledge of long sales cycles, and a double technical-commercial skill, Raïssa joins EcoMundo in Paris in 2020.
Anthony DELAMOTTE
BU AFNOR Médical Director
Anthony Delamotte is Director of AFNOR Médical, a Business Unit of AFNOR Certification in charge of assessing the regulatory and normative conformity of medical devices. He manages the project for the designation of the second French notified body.
© EcoMundo 2020
