In Vitro Diagnostic Medical Device
Regulation (IVDR) Training (EU) 2017/746
Our team of experts have created a 2-day course that focuses on the application of the key principles and practices required for the new In Vitro Diagnostic Medical Devices Regulation.
The course is designed to enhance the level of understanding for those actively engaged with IVDs and placing them on the market. Our tutors give you the necessary skills to perform the changes required to meet the new regulation.
By the end of this practical and interactive course, you will understand the changes and new requirements of the IVDR, be able to plan and conduct the changes and upgrades required to the quality management system and the technical files for in vitro devices.
Learning objectives include:
▪ Requirements for manufacturers and economic operators
▪ Classification and recognition of devices
▪ Risk analysis and trending
▪ Safety and performance requirements
▪ Routes to conformity
▪ The Unique Device Identifier (UDI)
▪ Performance evaluation
▪ Post-market surveillance and associated reports
Who should attend?
The content will have great value to individuals who are involved in any aspect of implementing or maintaining regulatory compliance with the new Regulation.
▪ Quality assurance professionals
▪ Quality Engineers
▪ Research and design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals
What will I receive?
▪ Detailed course notes
▪ A Meddev Solutions Training course certificate
▪ Lunch and refreshments provided both days
How much is the course?
This course is £675 per person. This price is inclusive of VAT.
Travel and accommodation is not included in the price. If required, our team is on hand to help you make your travel arrangements and offer accommodation recommendations.
Prefer online training? We offer that too!
Our online interactive course provides an introduction to the application
of the key principles and practices required for the new In Vitro Diagnostic
Medical Devices Regulation.
Duration: 7 hours
Release Date: Coming Soon
We have partnered with Comply Guru to bring you a growing library of Online Medical Device Regulatory Affairs Courses!
Comply Guru offers industry-leading online and blended training solutions to enable learners to get the knowledge and skills they need, from the same systems and devices they use every day!
Each one of our courses has been created by our expert team of consultants to ensure that all of our courses deliver you the right knowledge in a meaningful way that will meet your needs.
Take a look at our IVDR online course offerings below!