In Vitro Diagnostic Regulation (IVDR) Training

In Vitro Diagnostic Regulation (EU) 2017/746 

Category: IVDR Training, EU 2017/745 relating to IVDR 

Course Overview

 

This two day IVDR training course focuses on the application of the key principles and practices required for the new In Vitro Diagnostic Medical Devices Regulation. The IVDR will replace the current EU Directive on in vitro diagnostic medical devices (98/79/EC) and will be effective in all EU member and EFTA states. 

During this two day training course, you will gain an appreciation for the changes and new requirements of the IVDR and take away practical skills and guidance on how to transition to the new regulation.  

Course Content 

▪    EUDAMED

▪    Routes to conformity

▪    Performance evaluation

▪    Risk analysis and trending

▪    The Unique Device Identifier (UDI)

▪    Safety and performance requirements

▪    Classification and recognition of devices

▪    Post-market surveillance and associated reports

▪    Requirements for manufacturers and economic operators

Who should attend?

This course has been designed to enhance the level of understanding for those actively engaged with IVDs and placing them on the market.

▪    Quality Assurance professionals

▪    Quality Engineers

▪    Research and Design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

What will I receive? 

▪    Lunch

▪    Refreshments 

▪    Training course notes 

▪    Meddev Solutions IVDR training course certificate 

On-site Training

Any of our courses can be delivered on-site at your premises. 

 

Contact us today to find out more.

Book your place →

Due to COVID-19 this course has been transferred to an online virtual classroom.

Address

Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk

Social

  • LinkedIn
  • Facebook

Copyright © 2020 Meddev Solutions Ltd. All rights reserved.          Privacy Policy