TRAINING MODULES
The program aims to dive deep in to each topic with Real-World examples and to help professionals from medical devices industry to gain insights and hands on experience on solving compliance related problems in Medical Devices industry.
1- Product Technical Documents for Regulatory Submissions
2- Regulatory Submissions - US FDA
3- Regulatory Submissions - EU
4- Regulatory Submissions - APAC
5- Regulatory Submissions - LATAM
6- Regulatory Submissions - ANZ
7- Quality Management System - Development
8- Quality Management System - Implementation
9- Labelling for Global Regulatory Submissions
10- UDI - EUDAMED Requirements
11- Medical Writing for Regulatory Submissions
12 - Clinical Evaluation - Plan and Report
13 - Performance Evaluation - Plan and Report
14 - Post Marketing Surveillance Requirements
15 - Regulatory Projects for Each Topic
Duration
100 Hours
Training Format
On-Site, In-Person Training in a batch of 20 max.
Training Fee
Avaliable on request, please email to us at info@artixio.com