In Vitro Diagnostic Regulation (EU) 2017/746
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.
Our 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.
This course is designed to enhance the level of understanding for those actively engaged with IVDs and placing them on the market. Our expert tutors give you the necessary skills to perform the changes required to meet the new regulation.
By the end of this practical course, delegates will understand the changes and new requirements of the IVDR and be able to plan and conduct the changes and upgrades required to the quality management system and the technical files for in vitro devices.
▪ 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
Day 1: 8:30am - 16:30pm
Day 2: 9:00am - 16:30pm
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
This is a classroom based course filled with practical and interactive activities to embed your learning.
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?
▪ Training course notes, slides and handouts
▪ IVDR training course certificate
Our team Is on hand to support you with any B&B bookings if required.
Any of our courses can be delivered on-site at your premises.
Contact us today to find out more.