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IVDR – Key elements for successful transition to the new regulation

Regulation (EU) 2017/746 (IVDR) sets a new milestone in the regulation of IVD medical devices but also creates new regulatory challenges for manufacturers who are now required to fully revise their quality management system and technical documentation for all products. With our keynote we update you on the most relevant changes that are being introduced by the IVDR and which should be reflected in your business planning. We particularly emphasize the transitional rules that may help you in business continuation. Benefit from our experience we gained through implementation projects in which we helped manufactures to meet the new requirements of the IVDR.

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