MDD to MDR Conversion
Prepare for a smooth transition into the Regulations in the EU. The deadline for compliance with the European Medical Device Regulation (EU-MDR) is May 2020. Manufacturers are strongly advised to start considering the impact on their activities as soon as possible. To succeed in complying to the EU-MDR timely, the following elements are: Structural approach, Planning and Regulatory knowledge. Implementing the EU-MDR requires a structural approach since the transition to the EU-MDR CE certificates can last over several years.
To provide participants with the knowledge to assist their companies in preparing for a smooth transition into the regulations in the EU. Management personnel responsible for all aspects of CE marking medical devices will benefit from this course. Participants will gain in-depth knowledge of the change and EU-MDR requirements and on a strategy to analyze the impact and prepare for the transition.
Who should attend
- Internal and External Auditors
- Quality Managers
- Regulatory Affairs Managers.
There is no prerequisite for this course.
We offer open enrolment, on-location, train-the-trainer formats
For more details, contact us