MDD to MDR Coversion training

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TRAINING

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.

 

 

 

 

Program Overview

Duration: 1 or 2 days

  • Medical Device Regulation
  • Transition Planning

Learning Objectives

  • Understand the key changes upcoming in the new EU MDR
  • Understand the essence of early start in the transition
  • Understand how to prepare a transition plan.

Who should attend

  • Internal and External Auditors
  • Quality Managers
  • Regulatory Affairs Managers.

There is no prerequisite for this course.

Costs

We offer open enrolment, on-location, train-the-trainer formats

For more details, contact us  

 

 

 

 

 

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