Approval

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.

approval_medical

To achieve this, we concentrate on the following topics:

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    European Medical Device Regulation (MDR): Converting old standards into new standards (norms, liability, certification)

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    Jointly overcoming regulatory hurdles in the certification process

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

Head of Working Group

Simon Schlagintweit

TÜV Süd Product Service GmbH

Dr. Cora Lüders-Theuerkauf

Network Manager Medical

The following are involved in the working group

DMRC
ExOne
Expertants
simufact
Hofmann
FIT
Additive Industries
Ultimaker
GMH Gruppe
Gefertec
3D Systems
Hachtel
iGo3D
materialise
HP
DSM
Eos
DYE Mansion
Tüv Süd