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Advanced Training on Medical Devices Compliance

On-Site Training

100 Hours


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


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 

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