TRAINING
IVDR Transition
The new IVDR brings about many changes, including many definitions, new conformity assessment routes, new Notified Body designations and more. On top of that, there is a completely revised rule-based classification system and stricter requirements for safety and on analytical and clinical performance. Much more details have been included in the general safety and performance requirements replacing the current essential principles of the Directive, and above all: no grandfathering.
This training focusses on practical guidance to implement IVDR from determining the gaps from your current documentation and processes and the IVDR requirements. Gap assessments in QMS, technical files and analytical and clinical performance will be necessary to comprehend the scope of implementation required in your organization.
The training will clarify the new classification rules in detail and provide methods to determine the impact of the regulation through product portfolio review and prioritization. High-level project planning will be included. The day will be filled with discussions and case studies.
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.