The new MDR is now in effect but there is still a lot of work to be done to ensure long term compliance and readiness.
Our regulatory and globalization experts reviewed strategies for MedTech companies, to implement for long term MDR compliance.
Learn 5 key changes to technical documentation that impact Medical Devices manufacturers. Discover globalization strategies around product labeling, quality reporting and post market surveillance. This includes approaches to streamline change management, volume updates, and continuous translations.
Aline 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.