Overview

The regulatory environment for medical devices in Europe is still dramatically changing, the European Medical Device Regulation (MDR) has introduced new requirements and processes focusing on patient safety. This virtual live training course provides insights into the MDR and the practical implications for manufacturers and decision makers.

The course is designed to guide through the main challenges associated with conformity to MDR, including classification and the requirements for the vigilance system, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies. In interactive practical exercises participants will gain understanding of product demarcation, classification, and the need of an integrated pathway for Drug-Device Combination (DDC) products.

Additionally, some case studies will be shown how to implement the requirements. Delegates will have the opportunity to discuss the complexities involved with experts who have significant knowledge and experience in this field.

Featured topics

Background, Objectives and Key Elements of the MDR
Medical Device Coordination Group (MDCG)
Demarcation and Classification of Medical Devices
Software as Medical Device
General Safety and Performance Requirements (GSPR)
Post-Market Surveillance and Vigilance
Drug-Device Combination Products
Clinical Evaluation and Clinical Investigations

Who should attend?

This virtual live training course will be of importance to all those involved in the following departments:

Regulatory Affairs
Safety/Pharmacovigilance
PMS and Vigilance
Quality Assurance
Product registration and distribution

and all those interested in new EU MDR requirements.

Learning objectives

Gain a comprehensive understanding of the current requirements of the MDR and learn from case studies how to implement these requirements
Learn about the demarcation process and classification of medical devices according to risk classes
Learn from case studies how risks for the product can be managed over lifetime
Recognize the different stakeholders involved, besides the Notified Bodies
Realize the challenges for Combination products in the EU, and learn from recent guidelines

TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
Mac OS X: 10.5, 10.6, 10.7
Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirement

Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
Mac OS X: Intel processor, At least 512 MB RAM
Linux: At least 512 MB RAM

Display

800x600 pixel resolution or greater (1024x768 pixels recommended)

Digital Learning Catalog

Download

Have an account?

Register

Essentials of Medical Devices and Combination Products in the European Union