Virtual Conference

MDR Long Term Compliance and Global Translation Readiness

24 June 2021 | 14:00 BST | Online

Join our experts to discuss 5 crucial changes to technical documentation and how these will impact Medical Devices manufacturers.

Although the new MDR went into effect last month, there is still plenty of work to be done to ensure long term compliance and readiness.

Our regulatory and globalization experts will review strategies that MedTech companies can implement for long term MDR compliance.

We’ll go over a review of the 5 key changes to technical documentation that impact Medical Devices manufacturers. We’ll discuss globalization strategies around product labeling, quality reporting and post market surveillance. This will include approaches to streamline change management, volume updates, and continuous translations.  

Why Attend?

Join us in this live session to discover:

  • How long term MDR compliance is evolving
  • How different globalization strategies impact product labeling, quality reporting and post market surveillance
  • Multiple approaches to streamline change management, volume updates, and continuous translations

 

Meet the Speakers

Eline Dirven

Consultant Regulatory, Medical Devices, Zwiers Regulatory Consulting

Eline Dirven is a regulatory affairs consultant at Zwiers Regulatory Consultancy with a passion for medical devices. She has a background in biomedical sciences (research) and her experience ranges from device development to maintaining devices on the European market. Her expertise is not only limited to regulatory affairs, but also includes quality assurance such as ISO 13485 auditing, aligning procedures with latest (regulatory) requirements and providing trainings.  

Anne Ertlé

Sr. Director Language Services, Amplexor Life Sciences 

Anne Ertlé is Sales Director for EMEA and ASPAC at Amplexor Life Sciences. A seasoned Life Sciences executive, Anne has helped pharma companies streamline their labeling processes. Her global business development and leadership skills are focused on growing pipelines in diverse environments. A French national, Anne has lived in France, the United States and Asia.  

Registration

MDR Long Term Compliance and Global Translation Readiness

24 June 2021 | 14:00 BST | Online