Approval

Focuses on gaining approval for 3D-printed medical devices and components.

One essential requirement for operating successfully on any market is to always stay up to date with the latest legal restrictions or necessary certifications for your business segment.

This working group’s main task is to have a close look at the current status quo in order to define what is needed to gain approval for 3D-printed medical devices and to establish them in the industry.

Simon Schlagintweit

Medical Expert & Lead Auditor

TÜV Süd Production Service GmbH

European Medical Device Regulation (MDR)

Converting old standards into new standards (norms, liability, certification)

Regulatory Hurdles

Jointly overcoming regulatory hurdles in the certification process

Know-How transfer

Leveraging know-how transfer by inviting specialists in MDR, quality management, end-to-end solutions, point-of-care manufacturing, cost management, etc.