To be on the ball of the regulatory requirements is the foundation for operating successfully in the market. Our working group “Approval” is assigned to define what is needed to successfully integrate 3D-printed medical devices into the industry. The following main topics will be dealt with:
Converting old standards into new standards
(norms, liability, certification, MDR)
Adapting guidelines for custom-made as well as serial-produced devices
Taking advantage of know-how transfer by inviting specialists in MDR, DRG, Liability
Head of Working Group
Simon Schlagintweit TÜV Süd Product Service GmbH
MGA: Dr. Cora Lüders-Theuerkauf