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07 - 09 November 2023

Live Online Training Course | Delivered In CET Time Zone

07 - 09 November 2023

Live Online Training Course | Delivered In CET Time Zone

A Comprehensive Overview of the Medical Device Life-Cycle to Accelerate Your Path to Global Submission and Avoid Costly Delays - Delivered by an Expert Faculty

Course Overview

Develop your understanding of the very fundamentals of the medical device industry through this Medical Device School interactive training course. Navigate through the entire medical device lifecycle by immersing yourself in 3 days of sessions: from introductions to all stakeholders in the medical device ecosystem, regulatory pathways for device approval and post-market considerations. Additionally, benefit from engaging with ten specialised trainers, all of whom have extensive first-hand experiences with bringing medical devices to market and adhering to the complex global regulatory landscape.  

What will you learn?

Navigating the Current Medical Device Regulation (MDR)

Understand the key requirements of the EU MDR

Understand the medical device ecosystem and how all stakeholders interact to bring devices to market

Device regulation essentials

Learn the fundamentals of device regulations such as classification and conformity assessment

Biocompatibility

Discover the importance of biocompatibility and how to conduct biological evaluations

Risk Management

Risk management - Examine the importance of having a robust risk management plan

Clinical Investigations For Devices

Gain an insight into clinical investigations for devices

Implementing A Quality Management System

Understand the need of having a quality management system in place

Post Market Surveillance

Gain an insight into post market surveillance and vigilance to ensure your devices continue to be safe on the market

Access To The UK Market

Examine the evolving requirements of the UKCA mark and how to launch medical device products on the UK market

Who is this course for?

The school is designed for all those who want to improve and broaden their knowledge of the medical devices industry, whether you are an existing employee, graduate, new to an area/department or somebody who would benefit for future career development.

Professor

NTNU:

Norwegian University of Science and Technology

Eye-opener in regards to some of the challenges connected to medical devices in the 21st century.