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.