Medical Devices – Quality and Approval at a Glance

Only for EKFZ Academy members

Speaker

Dr. Sabine Hauck (dequra consulting sabine hauck)

Description

• How can approval for medical devices be achieved in a complex regulatory environment? The interactive EKFZ Academy workshop “Medical Devices – Quality and Approval at a Glance” guides you through the regulatory requirements and gives a comprehensive overview of product development and documentation. Dr. Sabine Hauck will discuss the differences between medical devices and medicinal products as well as the regulatory framework in the USA and EU. Furthermore, she will provide valuable insights into product development and focus on quality management and documentation. Afterwards, workshop participants will have the opportunity to network and discuss open questions with Sabine Hauck while enjoying drinks and finger food.