TRAINING
Fundamentals of the IVDR
There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the In Vitro Diagnostics Regulation (IVDR) is more complex and detailed and will, therefore, require more recourses to maintain as well as implement.
This first course of the IVDR trainings is an introduction of the In Vitro Diagnostics Regulation. The aim of the course is to learn what you need to know before you start IVDR implementation. Understand the key concepts so that you can build an IVDR transition plan or start CE marking for the first time. Manufacturers often think this part is redundant but it avoids making simple mistakes and avoiding non-conformities.
Program overview
Duration: 2 hours (virtual or customized in-house, to be determined in consultation)
- Introduction of the IVDR
- Setting the Scene
- Definitions and Key Concepts
- Responsibilities
- Classification and Conformity Routes
- First Steps
- The Notified Body Process
- What's next
- Final remarks
Who should attend?
- Senior Management
- Regulatory Affairs Managers, Quality Managers and/or Directors
- Clinical Affairs
- R&D, Product Development, Manufacturer, Operations and Marketing Managers
- International registration department
There is no prerequisite level for this course.
Costs
- Price on application for customized trainings, tailored workshops, on-location training, train-the-trainer formats or multiple training courses
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.