| |
March, 2020
Training Announcement !
April 21 to 23, 2020
European Medical Device Regulation
2017/745 & Clinical Evaluation Reports (CER)
GMED North America designed a comprehensive 3-day training course for the preparation and application framework surrounding CE marking under the EU MDR 2017/745, to help Medical Device companies understand the expectations of the new Regulation, including those pertaining to the Clinical Data Requirements and their implications on Clinical Evaluation Reports (CERs).
Learning Objectives:
- Assess the impacts of those changes on their organizational and structural activities
- Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s);
- Address the Quality Management System (QMS) requirements;
- Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
- Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management, including Post- Market Clinical Follow- Up;
- Implement the requirements for labeling, the Unique Device Identification (UDI) and EUDAMED;
- Understand the expectations for Clinical Investigation Requirements & “sufficient” clinical data(s);
- Address the requirements pertaining to Vigilance and Post- Market Surveillance Requirements (PMS), including Periodic Safety Update Report (PSUR);
Meet the Trainers
Florianne Torset-Bonfillou
Regulatory, and Education – Lead Auditor
|
|
|
Christopher Brodrick
CER & Design Dossier Evaluator
|
|
